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Home » Topics » Drugs » Biosimilar

Biosimilar
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Congress looking for ‘simple solutions’ to Rx pricing quandary

July 18, 2024
By Mari Serebrov
The bill the U.S. Senate passed to prune biologic patent thickets could be among the first in a legislative thicket aimed at prescription drug prices to make it through the Senate before the year ends.
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US Senate passes effort to prune biologic patent thickets

July 15, 2024
By Mari Serebrov
A bipartisan bill aimed at limiting patent thickets on biologics moved a step closer to law July 11 when the Senate passed it with unanimous consent in an unexpected vote that came more than one-and-a-half years after the Judiciary Committee reported it favorably to the Senate floor. The Affordable Prescriptions for Patients Act, S. 150, which would limit the type and number of patents that can be litigated under the Biologics Price Competition and Innovation Act (BPCIA), now awaits House action.
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Is enforcement enough to address PBM issues?

July 11, 2024
By Mari Serebrov
Just a day after the U.S. FTC released an interim report on harmful pharmacy benefit manager (PBM) practices and appeared before a House subcommittee that encouraged the commissioners to take enforcement action, the agency reportedly was preparing to file suit against the country’s three largest PBMs over their practices in negotiating insulin and other drug prices.
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Few surprises in FTC’s interim report on PBM practices

July 9, 2024
By Mari Serebrov
The redacted interim report released July 9 of an ongoing FTC investigation into pharmacy benefit managers (PBMs) shed little, if any, new insight into PBM practices and how they impact availability and pricing of prescription drugs in the U.S.
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Alteogen’s Altos nabs ₩24.5B in series B to develop new eye drug

July 9, 2024
By Marian (YoonJee) Chu
Altos Biologics Inc., founded as an eye disease-focused subsidiary of Alteogen Inc. in 2020, raised ₩24.5 billion (US$17.7 million) in a series B financing round to advance its pipeline of therapeutics for eye-related conditions, including age-related macular degeneration (AMD). Daejeon, South Korea-based Alteogen said July 9 that the funds raised will be funneled to develop OP-01, Altos’ candidate therapy for AMD.
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Red wooden approved stamp

China approves first cetuximab biosimilar

July 2, 2024
By Tamra Sami
China’s National Medical Products Administration authorized the country’s first cetuximab biosimilar with the approval of Simcere Zaiming’s Enlituo (CMAB-009, cetuximab beta injection) in combination with chemotherapy as first-line treatment for RAS/BRAF wild-type metastatic colorectal cancer. The biosimilar references originator drug Erbitux (cetuximab, Eli Lilly and Co.).
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Drug vials

FDA grants approvals to Stelara, Neupogen, Eylea biosimilars

July 2, 2024
By Marian (YoonJee) Chu
The U.S. FDA approved three biosimilar products from Samsung Bioepis Co. Ltd., Tanvex Biopharma Inc. and Formycon AG as follow-on biologics to Stelara (ustekinumab), Neupogen (filgrastim) and Eylea (aflibercept), respectively, on June 28.
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Fosun Pharma to buy out Henlius in $691.7M merger deal

June 25, 2024
By Tamra Sami
Shanghai Fosun Pharmaceutical Co. Ltd announced it will buy out partner Shanghai Henlius Biotech Inc. for up to HKD$5.4 billion (US$691.7 million), according to a joint announcement on the Hong Kong Stock Exchange.
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Informed by experience, FDA updating interchangeability guidance

June 20, 2024
By Mari Serebrov
Now that it has some experience with interchangeable biosimilars under its belt, the U.S. FDA is proposing an update to its interchangeability guidance that could eliminate the need for switching studies in some instances.
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Celltrion seeks US IND nod for Keytruda biosimilar phase III

June 18, 2024
By Marian (YoonJee) Chu
As competition rises in the Keytruda (pembrolizumab) biosimilar space, Celltrion Inc. is the latest to announce that it filed an IND application to the U.S. FDA to start a global phase III trial for its own Keytruda biosimilar, dubbed CT-P51. Incheon, South Korea-based Celltrion, which previously said it would differentiate from the pack by developing an easier-to-administer subcutaneous biosimilar of pembrolizumab, announced June 17 plans to start a global comparative phase III study of CT-P51 and Keytruda.
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