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    <title>Biosimilar</title>
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    <item>
      <title>South Korea streamlines biosimilar review, clinical trials</title>
      <description>
        <![CDATA[South Korea is rolling out regulatory changes to speed biosimilar development, including reforms to shorten review timelines, ease phase III trial requirements and simplify oversight of manufacturing changes.&nbsp;]]>
      </description>
      <guid>http://www.bioworld.com/articles/730137</guid>
      <pubDate>Tue, 07 Apr 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730137-south-korea-streamlines-biosimilar-review-clinical-trials</link>
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        <media:title type="plain">Drug vials and syringe</media:title>
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    <item>
      <title>US FDA draft guidance eases another biosimilar requirement</title>
      <description>
        <![CDATA[In releasing its latest revision of a draft guidance on biosimilars and interchangeable biosimilars, the U.S. FDA took another step in streamlining the development of the follow-ons by easing unnecessary clinical pharmacokinetic testing involving comparator biologics approved outside the U.S.]]>
      </description>
      <guid>http://www.bioworld.com/articles/729451</guid>
      <pubDate>Tue, 10 Mar 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/729451-us-fda-draft-guidance-eases-another-biosimilar-requirement</link>
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        <media:title type="plain">Magnifying glass atop paperwork</media:title>
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      <title>Jiuyuan seeks approval of Wegovy biosimilar in China</title>
      <description>
        <![CDATA[China’s National Medical Products Administration has accepted for review Jiuyuan Genetic Biopharmaceutical Co. Ltd.’s drug application for Jikeqin, a biosimilar product to Novo Nordisk A/S’s Wegovy (semaglutide) for obesity.]]>
      </description>
      <guid>http://www.bioworld.com/articles/729318</guid>
      <pubDate>Tue, 03 Mar 2026 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/729318-jiuyuan-seeks-approval-of-wegovy-biosimilar-in-china</link>
    </item>
    <item>
      <title>Jiuyuan seeks approval of Wegovy biosimilar in China</title>
      <description>
        <![CDATA[China’s National Medical Products Administration has accepted for review Jiuyuan Genetic Biopharmaceutical Co. Ltd.’s drug application for Jikeqin, a biosimilar product to Novo Nordisk A/S’s Wegovy (semaglutide) for obesity.]]>
      </description>
      <guid>http://www.bioworld.com/articles/729245</guid>
      <pubDate>Thu, 26 Feb 2026 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/729245-jiuyuan-seeks-approval-of-wegovy-biosimilar-in-china</link>
    </item>
    <item>
      <title>Skinny labeling to get its day before the US Supreme Court</title>
      <description>
        <![CDATA[After passing on one skinny label case a few years ago, the U.S. Supreme Court agreed to delve into the dark hole the Federal Circuit has dug for drug label carveouts that allow generic drugs and biosimilars to come to market even though some indications of the reference drug may still be protected by exclusivities or patents. The high court granted cert Jan. 16 to Hikma Pharmaceuticals v. Amarin Pharma Inc., which revolves around Hikma’s marketing of its generic version of Amarin’s blockbuster drug, Vascepa (icosapent ethyl).]]>
      </description>
      <guid>http://www.bioworld.com/articles/728135</guid>
      <pubDate>Tue, 20 Jan 2026 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/728135-skinny-labeling-to-get-its-day-before-the-us-supreme-court</link>
    </item>
    <item>
      <title>EMA marks 2025 2nd busiest year, says pace will continue in 2026</title>
      <description>
        <![CDATA[The EMA had its second busiest year ever in 2025, approving 104 drugs, of which 38 had a new active substance. Sixteen of these are for treating rare diseases, and four are advanced therapy medicinal products.]]>
      </description>
      <guid>http://www.bioworld.com/articles/727992</guid>
      <pubDate>Thu, 15 Jan 2026 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/727992-ema-marks-2025-2nd-busiest-year-says-pace-will-continue-in-2026</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/EMA-icons.webp?t=1619205754" type="image/png" medium="image" fileSize="406915">
        <media:title type="plain">EMA icons</media:title>
      </media:content>
    </item>
    <item>
      <title>China approves Innovent’s ipilimumab for colon cancer</title>
      <description>
        <![CDATA[China’s National Medical Products Administration approved Innovent Biologics Inc.’s NDA for Tabosun (ipilimumab N01, IBI-310) in combination with sintilimab as neoadjuvant treatment for stage IIB-III resectable microsatellite instability-high or mismatch repair deficient colon cancer.]]>
      </description>
      <guid>http://www.bioworld.com/articles/727635</guid>
      <pubDate>Tue, 30 Dec 2025 00:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/727635-china-approves-innovents-ipilimumab-for-colon-cancer</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Therapeutic-topics/Gastrointestinal/Gastrointestinal-vector-framework.webp?t=1739806991" type="image/jpeg" medium="image" fileSize="232822">
        <media:title type="plain">Illustration of intestinal track</media:title>
      </media:content>
    </item>
    <item>
      <title>China approves Innovent’s ipilimumab for colon cancer</title>
      <description>
        <![CDATA[China’s National Medical Products Administration approved Innovent Biologics Inc.’s NDA for Tabosun (ipilimumab N01, IBI-310) in combination with sintilimab as neoadjuvant treatment for stage IIB-III resectable microsatellite instability-high or mismatch repair deficient colon cancer.]]>
      </description>
      <guid>http://www.bioworld.com/articles/727384</guid>
      <pubDate>Mon, 29 Dec 2025 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/727384-china-approves-innovents-ipilimumab-for-colon-cancer</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Therapeutic-topics/Gastrointestinal/Gastrointestinal-vector-framework.webp?t=1739806991" type="image/jpeg" medium="image" fileSize="232822">
        <media:title type="plain">Illustration of intestinal track</media:title>
      </media:content>
    </item>
    <item>
      <title>Big pharma taps fast Asia innovation in search of next Keytruda</title>
      <description>
        <![CDATA[Speed and innovation from Asia Pacific’s (APAC) biotechnology sector had big pharma scouring the region for the next oncology heir to Keytruda (pembrolizumab), Merck & Co. Inc.’s reigning blockbuster cancer drug.]]>
      </description>
      <guid>http://www.bioworld.com/articles/727509</guid>
      <pubDate>Tue, 23 Dec 2025 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/727509-big-pharma-taps-fast-asia-innovation-in-search-of-next-keytruda</link>
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        <media:title type="plain">Asia focused map inside light bulb</media:title>
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    </item>
    <item>
      <title>FDA ad guidance neuters biosimilar/interchangeable distinction </title>
      <description>
        <![CDATA[While the U.S. Congress has yet to address the artificial line it created between biosimilars and interchangeables when it passed the Biologics Price Competition and Innovation Act in 2010, the FDA is erasing that distinction for all practical purposes.]]>
      </description>
      <guid>http://www.bioworld.com/articles/726878</guid>
      <pubDate>Tue, 09 Dec 2025 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/726878-fda-ad-guidance-neuters-biosimilar-interchangeable-distinction</link>
    </item>
    <item>
      <title>14 psoriasis therapies projected to launch in China by 2027</title>
      <description>
        <![CDATA[Fourteen therapies to treat moderate to severe psoriasis are expected to enter the Chinese market in the next two years, according to Clarivate and <em>BioWorld</em> reports. Eleven of them are being developed by domestic biopharmaceutical firms.]]>
      </description>
      <guid>http://www.bioworld.com/articles/726866</guid>
      <pubDate>Mon, 08 Dec 2025 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/726866-14-psoriasis-therapies-projected-to-launch-in-china-by-2027</link>
    </item>
    <item>
      <title>Despite expectations, insulin biosimilars see slow uptake in US </title>
      <description>
        <![CDATA[The Sept. 4, 2015, at-risk launch of Sandoz Inc.’s Zarxio as the first biosimilar to hit the U.S. market came several months after the FDA had approved the filgrastim biosimilar due to a court battle over the requirements of the 2010 Biologics Price Competition and Innovation Act, which laid out the rules of the road for the new class of follow-on drugs. Ten years later, biosimilar developers are still struggling with some of those rules that were drafted by Congress in an effort to balance competition with innovation in the biologics space. Insulin biosimilars may be the hardest hit.]]>
      </description>
      <guid>http://www.bioworld.com/articles/726507</guid>
      <pubDate>Wed, 26 Nov 2025 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/726507-despite-expectations-insulin-biosimilars-see-slow-uptake-in-us</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Drugs/US-flag-cart-of-vials.webp?t=1665432776" type="image/png" medium="image" fileSize="194525">
        <media:title type="plain">US flag, shopping cart of vials </media:title>
      </media:content>
    </item>
    <item>
      <title>10 years on, US biosimilars staring down the void</title>
      <description>
        <![CDATA[It’s been a decade since Sandoz Inc. launched Zarxio, referencing Amgen Inc.’s Neupogen (filgrastim), as the first biosimilar in the U.S. Zarxio was expected to be the beginning of a biosimilar boom that would deliver big savings by finally providing direct competition for costly biologics. Neither the pipeline nor the uptake of biosimilars has lived up to expectations, as only 6% of the 313 biologics approved by the FDA’s CDER have been targeted by biosimilars and fewer than 5% are actually competing with the follow-ons.]]>
      </description>
      <guid>http://www.bioworld.com/articles/726494</guid>
      <pubDate>Tue, 25 Nov 2025 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/726494-10-years-on-us-biosimilars-staring-down-the-void</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Drugs/Blue-and-red-vials.webp?t=1665614322" type="image/png" medium="image" fileSize="296502">
        <media:title type="plain">Blue-and-red-vials.png</media:title>
      </media:content>
    </item>
    <item>
      <title>New Samyang Holdings, Samsung Biologics spin-offs debut on Kospi </title>
      <description>
        <![CDATA[Two South Korean conglomerates – Samyang Holdings Corp. and Samsung Biologics Co. Ltd. – listed their newly spun-off biopharmaceutical units on Korea Exchange’s (KRX) main trading board Nov. 24.]]>
      </description>
      <guid>http://www.bioworld.com/articles/726484</guid>
      <pubDate>Mon, 24 Nov 2025 11:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/726484-new-samyang-holdings-samsung-biologics-spin-offs-debut-on-kospi</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Money/Gray-Korean-Won-sign.webp?t=1731708866" type="image/jpeg" medium="image" fileSize="105191">
        <media:title type="plain">Korean Won currency symbol made of gray cast iron</media:title>
      </media:content>
    </item>
    <item>
      <title>Henlius, Organon win US FDA approval of first Perjeta biosimilar</title>
      <description>
        <![CDATA[Shanghai Henlius Biotech Inc. and Organon & Co. announced Nov. 17 that the U.S. FDA cleared Poherdy (pertuzumab-dpzb) as the first and only interchangeable biosimilar to Perjeta (pertuzumab, Genentech Inc./Roche Holding AG).]]>
      </description>
      <guid>http://www.bioworld.com/articles/726252</guid>
      <pubDate>Tue, 18 Nov 2025 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/726252-henlius-organon-win-us-fda-approval-of-first-perjeta-biosimilar</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/FDA-approved-stamp3.webp?t=1591990896" type="image/png" medium="image" fileSize="172408">
        <media:title type="plain">FDA Approved stamp</media:title>
      </media:content>
    </item>
    <item>
      <title>Celltrion, Portrai in $87M R&amp;D deal to discover new drug targets</title>
      <description>
        <![CDATA[Celltrion Inc. announced Oct. 29 the signing of an $87.75 million joint drug R&D agreement with AI and spatial transcriptome-based biotech Portrai Inc.]]>
      </description>
      <guid>http://www.bioworld.com/articles/725902</guid>
      <pubDate>Tue, 04 Nov 2025 10:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/725902-celltrion-portrai-in-87m-r-and-d-deal-to-discover-new-drug-targets</link>
    </item>
    <item>
      <title>South Korea trade deal eases industry’s pharma tariff fears</title>
      <description>
        <![CDATA[The Korea Biotechnology Industry Organization on Oct. 30 welcomed the bilateral trade deal between the U.S. and South Korea announced during U.S. President Donald Trump’s state visit alongside the Asia-Pacific Economic Cooperation forum in Gyeongju, South Korea.]]>
      </description>
      <guid>http://www.bioworld.com/articles/725900</guid>
      <pubDate>Tue, 04 Nov 2025 08:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/725900-south-korea-trade-deal-eases-industrys-pharma-tariff-fears</link>
      <media:content url="https://www.bioworld.com/ext/resources/BW-source/2025/Donald-Trump-and-Lee-Jae-myung-10-30.webp?t=1761848731" type="image/jpeg" medium="image" fileSize="595818">
        <media:title type="plain">U.S. President Donald J. Trump (left) and South Korea President Lee Jae-myung at the ROK-U.S. summit</media:title>
        <media:description type="plain">U.S. President Donald J. Trump (left) and South Korea President Lee Jae-myung at the ROK-U.S. summit in Gyeongju-si, South Korea Oct. 29. Source: Office of the President Republic of Korea</media:description>
      </media:content>
    </item>
    <item>
      <title>Celltrion, Portrai in $87M R&amp;D deal to discover new drug targets</title>
      <description>
        <![CDATA[Celltrion Inc. announced Oct. 29 the signing of an $87.75 million joint drug R&D agreement with AI and spatial transcriptome-based biotech Portrai Inc.]]>
      </description>
      <guid>http://www.bioworld.com/articles/725691</guid>
      <pubDate>Thu, 30 Oct 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/725691-celltrion-portrai-in-87m-r-and-d-deal-to-discover-new-drug-targets</link>
    </item>
    <item>
      <title>US, South Korea trade deal eases industry’s pharma tariff fears</title>
      <description>
        <![CDATA[The Korea Biotechnology Industry Organization on Oct. 30 welcomed the bilateral trade deal between the U.S. and South Korea announced during U.S. President Donald Trump’s state visit alongside the Asia-Pacific Economic Cooperation forum in Gyeongju, South Korea.]]>
      </description>
      <guid>http://www.bioworld.com/articles/725690</guid>
      <pubDate>Thu, 30 Oct 2025 09:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/725690-us-south-korea-trade-deal-eases-industrys-pharma-tariff-fears</link>
      <media:content url="https://www.bioworld.com/ext/resources/BW-source/2025/Donald-Trump-and-Lee-Jae-myung-10-30.webp?t=1761848731" type="image/jpeg" medium="image" fileSize="595818">
        <media:title type="plain">U.S. President Donald J. Trump (left) and South Korea President Lee Jae-myung at the ROK-U.S. summit</media:title>
        <media:description type="plain">U.S. President Donald J. Trump (left) and South Korea President Lee Jae-myung at the ROK-U.S. summit in Gyeongju-si, South Korea Oct. 29. Source: Office of the President Republic of Korea</media:description>
      </media:content>
    </item>
    <item>
      <title>US FDA paves way for biosimilars to be more like generics</title>
      <description>
        <![CDATA[Ten years after the first biosimilar launched on the U.S. market, the FDA is taking steps to make biosimilar development and pharmacy substitution more like that of generics, reducing the cost of the drugs in the process. “We want to see more biosimilars. We want to see more competition,” FDA Commissioner Marty Makary said at an Oct. 29 media briefing in which he announced new guidance to streamline biosimilar development, cut through the red tape and shorten the timeline.]]>
      </description>
      <guid>http://www.bioworld.com/articles/725593</guid>
      <pubDate>Wed, 29 Oct 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/725593-us-fda-paves-way-for-biosimilars-to-be-more-like-generics</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Drugs/Collection-of-vials.webp?t=1712686112" type="image/jpeg" medium="image" fileSize="382137">
        <media:title type="plain">Collection of vials</media:title>
      </media:content>
    </item>
    <item>
      <title>Celltrion to buy Lilly’s cGMP plant for $330M, invest up to $1B</title>
      <description>
        <![CDATA[Celltrion Inc. announced plans to acquire from Eli Lilly and Co. a Branchburg, N.J.-based biologics cGMP facility for $330 million up front, with plans to invest up to a total of ₩1.4 trillion (US$1 billion) in plant acquisition and expansion.]]>
      </description>
      <guid>http://www.bioworld.com/articles/724390</guid>
      <pubDate>Tue, 23 Sep 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/724390-celltrion-to-buy-lillys-cgmp-plant-for-330m-invest-up-to-1b</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Misc/Celltrion-signage.webp?t=1692390081" type="image/jpeg" medium="image" fileSize="272106">
        <media:title type="plain">Celltrion building and skyline</media:title>
        <media:description type="plain">Credit: Celltrion Inc.</media:description>
      </media:content>
    </item>
    <item>
      <title>CHMP recommends EU approval of Bayer’s Lynkuet for hot flashes</title>
      <description>
        <![CDATA[Following the first approvals in the U.K., Canada, Australia and Switzerland, the EMA’s Committee for Medicinal Products for Human Use (CHMP) is now recommending approval of Bayer AG’s Lynkuet (elinzanetant), a non-hormonal treatment for symptoms of menopause. The drug, the first dual neurokinin-1 and neurokinin-3 receptor antagonist, is for the treatment of moderate to severe vasomotor symptoms, also known as hot flashes.]]>
      </description>
      <guid>http://www.bioworld.com/articles/724310</guid>
      <pubDate>Fri, 19 Sep 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/724310-chmp-recommends-eu-approval-of-bayers-lynkuet-for-hot-flashes</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Drugs/Person-holding-pills-and-glass-of-water.webp?t=1744924970" type="image/jpeg" medium="image" fileSize="128864">
        <media:title type="plain">Person holding pills and glass of water</media:title>
      </media:content>
    </item>
    <item>
      <title>South Korea to hike biosimilar approval fees, slash review times</title>
      <description>
        <![CDATA[South Korea’s Ministry of Food and Drug Safety announced Sept. 12 plans to significantly raise drug application fees for biosimilars but slash their review times starting next year.]]>
      </description>
      <guid>http://www.bioworld.com/articles/724324</guid>
      <pubDate>Tue, 16 Sep 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/724324-south-korea-to-hike-biosimilar-approval-fees-slash-review-times</link>
      <media:content url="https://www.bioworld.com/ext/resources/BW-source/2025/Kim-Kyung-ah-CEO-Samsung-Bioepis-9-15.webp?t=1757969049" type="image/jpeg" medium="image" fileSize="331590">
        <media:title type="plain">Kim Kyung-ah, CEO, Samsung Bioepis</media:title>
        <media:description type="plain">Samsung Bioepis CEO Kim Kyung-ah calls for government-led incentive policies for biosimilar uptake Sept. 5.</media:description>
      </media:content>
    </item>
    <item>
      <title>South Korea to hike biosimilar approval fees, slash review times</title>
      <description>
        <![CDATA[South Korea’s Ministry of Food and Drug Safety announced Sept. 12 plans to significantly raise drug application fees for biosimilars but slash their review times starting next year.]]>
      </description>
      <guid>http://www.bioworld.com/articles/724161</guid>
      <pubDate>Mon, 15 Sep 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/724161-south-korea-to-hike-biosimilar-approval-fees-slash-review-times</link>
      <media:content url="https://www.bioworld.com/ext/resources/BW-source/2025/Kim-Kyung-ah-CEO-Samsung-Bioepis-9-15.webp?t=1757969049" type="image/jpeg" medium="image" fileSize="331590">
        <media:title type="plain">Kim Kyung-ah, CEO, Samsung Bioepis</media:title>
        <media:description type="plain">Samsung Bioepis CEO Kim Kyung-ah calls for government-led incentive policies for biosimilar uptake Sept. 5.</media:description>
      </media:content>
    </item>
    <item>
      <title>Europe approves Bio-Thera’s Stelara biosimilar</title>
      <description>
        <![CDATA[Bio-Thera Solutions Inc. announced Aug. 26 that the European Commission cleared Usymro (BAT-2206) as a biosimilar to Janssen Pharmaceuticals Inc.’s Stelara (ustekinumab). The EMA issued marketing authorization for Usymro on Aug. 14, following the EMA’s Committee for Medicinal Products for Human Use adopting a positive opinion on June 19.]]>
      </description>
      <guid>http://www.bioworld.com/articles/723859</guid>
      <pubDate>Tue, 02 Sep 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/723859-europe-approves-bio-theras-stelara-biosimilar</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Geographic-regions/Europe/European-flag-vaccine.webp?t=1650922336" type="image/png" medium="image" fileSize="294231">
        <media:title type="plain">European flag, vial, syringe</media:title>
      </media:content>
    </item>
    <item>
      <title>Ripples of IRA Rx price negotiations to be felt on competition</title>
      <description>
        <![CDATA[Three milestones expected to bring the reality of U.S. prescription drug price negotiations into focus are hovering on the horizon. First, the CMS is scheduled to publish its maximum fair prices (MFPs) for the round 2 selected drugs by Nov. 30. Then, on Jan. 1, the MFPs for the first round kick in, affecting not only the 10 selected drugs, but a dozen approved biosimilars referencing the three biologics in that round, 94 generics either approved or tentatively approved that reference the small molecules on the list, and perhaps other innovator drugs in the same therapeutic spaces. And by Feb. 1, CMS must publish the list of up to 15 drugs selected for negotiations for the 2028 price year. That list will be the first to include Part B drugs.]]>
      </description>
      <guid>http://www.bioworld.com/articles/723643</guid>
      <pubDate>Fri, 29 Aug 2025 09:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/723643-ripples-of-ira-rx-price-negotiations-to-be-felt-on-competition</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Drugs/Drug-pricing-illustration.webp?t=1598557470" type="image/png" medium="image" fileSize="365578">
        <media:title type="plain">Prescription drug bottle, pills shaped in $ sign</media:title>
      </media:content>
    </item>
    <item>
      <title>Europe approves Bio-Thera’s Stelara biosimilar</title>
      <description>
        <![CDATA[Bio-Thera Solutions Inc. announced Aug. 26 that the European Commission cleared Usymro (BAT-2206) as a biosimilar to Janssen Pharmaceuticals Inc.’s Stelara (ustekinumab). The EMA issued marketing authorization for Usymro on Aug. 14, following the EMA’s Committee for Medicinal Products for Human Use adopting a positive opinion on June 19.]]>
      </description>
      <guid>http://www.bioworld.com/articles/723329</guid>
      <pubDate>Wed, 27 Aug 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/723329-europe-approves-bio-theras-stelara-biosimilar</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Geographic-regions/Europe/European-flag-vaccine.webp?t=1650922336" type="image/png" medium="image" fileSize="294231">
        <media:title type="plain">European flag, vial, syringe</media:title>
      </media:content>
    </item>
    <item>
      <title>US FDA looking to help with Rx moving woes ahead of tariff</title>
      <description>
        <![CDATA[Location, location, location. While location is as important in manufacturing as it is in buying a home, it could become even more so for drug companies when, and if, the global biopharma sector tariff U.S. President Donald Trump continues to tease becomes a reality. In the shadow of the impending tariff, the FDA is working on a draft framework, the two-phase FDA PreCheck, to make it faster and easier for biopharma companies to relocate their manufacturing to the U.S.]]>
      </description>
      <guid>http://www.bioworld.com/articles/722939</guid>
      <pubDate>Thu, 07 Aug 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/722939-us-fda-looking-to-help-with-rx-moving-woes-ahead-of-tariff</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Geographic-regions/US/US-map-with-arrows-pointing-inward.webp?t=1754599645" type="image/jpeg" medium="image" fileSize="247248">
        <media:title type="plain">US map with arrows pointing inward</media:title>
      </media:content>
    </item>
    <item>
      <title>South Korea hits record $23B pharma production; 2024 exports up 28% </title>
      <description>
        <![CDATA[South Korea’s pharmaceutical manufacturing reached an all-time high of ₩32.86 trillion (US$23 billion) in 2024, representing a 7.3% increase from 2023 and the highest on record since the country began count in 1998.]]>
      </description>
      <guid>http://www.bioworld.com/articles/722712</guid>
      <pubDate>Tue, 29 Jul 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/722712-south-korea-hits-record-23b-pharma-production-2024-exports-up-28</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Drugs/Drug-manufacturing.webp?t=1588350006" type="image/png" medium="image" fileSize="429133">
        <media:title type="plain">Tablets on conveyor belt</media:title>
      </media:content>
    </item>
    <item>
      <title>South Korea hits record $23B pharma production; 2024 exports up 28% </title>
      <description>
        <![CDATA[South Korea’s pharmaceutical manufacturing reached an all-time high of ₩32.86 trillion (US$23 billion) in 2024, representing a 7.3% increase from 2023 and the highest on record since the country began count in 1998.]]>
      </description>
      <guid>http://www.bioworld.com/articles/722424</guid>
      <pubDate>Thu, 24 Jul 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/722424-south-korea-hits-record-23b-pharma-production-2024-exports-up-28</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Drugs/Drug-manufacturing.webp?t=1588350006" type="image/png" medium="image" fileSize="429133">
        <media:title type="plain">Tablets on conveyor belt</media:title>
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