Although last year’s massive U.S. launch of Humira biosimilars captured headlines, the market adoption of those competitors has been nothing to write home about, even with discounts as low as 85% off the innovator price.
As the U.S. FDA and the Advanced Research Projects Agency for Health (ARPA-H) move forward with new guidance and foundational data, they both recently issued requests for information (RFIs) to help them advance their agendas.
Samsung Bioepis Co. Ltd., of Incheon, South Korea, gained U.S. FDA approval of Epysqli (eculizumab-aagh) as the second biosimilar product to Alexion Pharmaceuticals Inc.’s Soliris (eculizumab) to treat two rare diseases. The regulatory clearance July 22 grants use of Epysqli to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome – two rare hematologic- and kidney-related disorders known to affect about 50,000 and 5,000 patients in the U.S., respectively.
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.
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.
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.
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.
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.
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.).
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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