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Approved stamp

South Korea approves record number of biosimilars in 2024

May 6, 2025
By Marian (YoonJee) Chu
South Korea’s Ministry of Food and Drug Safety approved 18 biosimilar products in 2024, making it a record year for domestic biosimilar approvals since the agency’s first nod of Celltrion Inc.’s Remsima, a reference product of Remicade (infliximab), in 2012.
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Approved stamp

South Korea approves record number of biosimilars in 2024

April 30, 2025
By Marian (YoonJee) Chu
South Korea’s Ministry of Food and Drug Safety approved 18 biosimilar products in 2024, making it a record year for domestic biosimilar approvals since the agency’s first nod of Celltrion Inc.’s Remsima, a reference product of Remicade (infliximab), in 2012.
Read More
Pill bottle spilling over EU flag

Many US tariffs paused, pharma warned, EU put on notice

April 9, 2025
By Mari Serebrov
The on-again, off-again U.S. tariffs are off again, at least for now, for more than 75 countries that have reached out to the Trump administration to negotiate instead of retaliating. The 90-day pause will provide some breathing room for the med-tech industry. Pharmaceuticals and active pharmaceutical ingredients were among the few products exempted from the reciprocal tariffs, but that exemption for pharmaceuticals was expected to be short-lived. Meanwhile, pharma CEOs warned European Commission President Ursula von der Leyen April 8 that, unless the EU quickly changes its policy, pharmaceutical research, development and manufacturing is increasingly likely to be directed to the U.S.
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Caution tape displaying US flag, tariffs

Biopharma exempt from US reciprocal tariffs, but not untouched

April 3, 2025
By Mari Serebrov
At first glance, it appears that biopharmaceuticals dodged the latest U.S. tariff bullet; med-tech, not so much. According to the executive order President Donald Trump signed in the Rose Garden late yesterday, pharmaceuticals are one of the few things exempt from the new country-by-country reciprocal tariffs that will be going into effect over the next week. However, U.S.-based manufacturers of both drugs and devices could face supply chain disruptions, further market restrictions and increased operating costs as the new tariffs take effect and other countries retaliate.
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Pharmaceutical manufacturing

As tariffs threaten US imports of APIs, companies reshore manufacturing

March 11, 2025
By Marian (YoonJee) Chu
While the U.S. has historically led the global pharmaceutical industry by pursuing both continual innovation and high quality, those strengths could become areas of weakness in times of political uncertainty, according to PA Consulting expert Andy Prinz.
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Pills spilling out of prescription bottle

Ending ‘pill penalty’ challenges sacred cow status of IRA

March 11, 2025
By Mari Serebrov
Getting the Ensuring Pathways to Innovative Cures (EPIC) Act through the U.S. Congress to do away with the “pill penalty” in the Medicare drug price negotiations could require an epic effort, given the current politically fueled atmosphere on the Hill. With the Inflation Reduction Act (IRA), which created the negotiations, considered a signature achievement of the Biden administration, the negotiations have become, for many lawmakers, almost a sacred cow that can’t be touched. If anything, some of them want to expand the negotiations to more drugs and to the commercial market.
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Pharmaceutical manufacturing

As tariffs threaten US imports of APIs, companies reshore manufacturing

March 10, 2025
By Marian (YoonJee) Chu
While the U.S. has historically led the global pharmaceutical industry by pursuing both continual innovation and high quality, those strengths could become areas of weakness in times of political uncertainty, according to PA Consulting expert Andy Prinz.
Read More
Gavel and pill blister packs

US Claims Court rules Vanda’s trade secrets not so secret

Jan. 24, 2025
By Mari Serebrov
A U.S. Federal Claims Court judge shot down Vanda Pharmaceuticals Inc.’s accusations that the FDA disclosed the company’s trade secrets to generic competitors, finding that the trade secrets weren’t really secret or necessarily proprietary to Vanda.
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Generic drugs and bottle

Drugsplaining: Teva details price negotiation impact on generics

Jan. 22, 2025
By Mari Serebrov
With more than five dozen generics already tentatively approved for 10 of the drugs selected for the next round of the Medicare Price Negotiation Program, the impact of the negotiations won’t be limited to just the brand drugs.
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New US FTC report likely to fuel further PBM reforms

Jan. 14, 2025
By Mari Serebrov
Pharmacy benefit managers (PBMs) are under the microscope again, this time for the price markups their affiliated specialty pharmacies charge for generic drugs used to treat cancer, HIV, multiple sclerosis and other serious conditions.
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