How many patents does it take to violate U.S. antitrust law? That question isn’t a lead-in to a lame joke. Neither is it a valid question for a patent challenge, according to the U.S. Court of Appeals for the Seventh Circuit, which Aug. 1 affirmed the dismissal of a payer suit against Abbvie Inc. that claimed the North Chicago drug company violated the Sherman Antitrust Act when it obtained 132 patents on Humira (adalimumab) and then invoked them against biosimilars.
Sunshine Guojian Pharmaceutical Co. Ltd. has granted Xiling Lab Pharmaceutical Co. Ltd. global rights to develop and commercialize the trastuzumab biosimilar Cipterbin (inetetamab) for antibody-drug conjugates (ADC) in a ¥1.03 billion (US$153 million) deal.
Sunshine Guojian Pharmaceutical Co. Ltd. has granted Xiling Lab Pharmaceutical Co. Ltd. global rights to develop and commercialize the trastuzumab biosimilar Cipterbin (inetetamab) for antibody-drug conjugates (ADC) in a ¥1.03 billion (US$153 million) deal.
The U.S. FTC isn’t waiting to complete its investigation into potentially anticompetitive practices of pharmacy benefit managers to crack down on some of those schemes.
What was billed as a U.S. Senate Health, Education, Labor and Pensions Committee hearing June 16 to get an update from top government health officials on the nation’s response to COVID-19 was, in reality, a concerted effort to get Republicans in the U.S. Senate to open the checkbook so the Biden administration could fill in the amount for more COVID-19 spending, Ranking Member Richard Burr (R-N.C.) charged as he concluded the hearing.
News that the U.S. FTC is finally going to reexamine the role of pharmaceutical benefit managers (PBMs) and their impact on prescription drug prices and availability is playing to applause from several sectors that have been complaining for years about PBM practices.
Although broader use of biosimilars in the U.S. would reduce Medicare Part D spending and save beneficiaries nearly $2 million in out-of-pocket costs, plan formularies continue to discourage the use of the more affordable follow-ons, according to a recent report from the Department of Health and Human Services’ Office of Inspector General.
Results from a phase III study comparing Celltrion Inc.’s biosimilar VEGF ligand inhibitor CT-P16 to Roche Holding AG’s Avastin (bevacizumab) in patients with metastatic or recurrent non-squamous non-small-cell lung cancer (NSCLC) found it to be similarly effective and as safe compared to the reference drug. Incheon, South Korea-based Celltrion presented the results at the 2022 annual meeting of the American Association for Cancer Research. The company now plans “to speed up the approval process through consultation with regulatory authorities in each country,” a Celltrion official said.
The U.S. biosimilar review process seems to be hitting its stride, with the FDA approving, in the first cycle, 67%, or 14, of the 21 biosimilar applications filed and acted upon in the first four years of BsUFA II.
2023 may be a pivotal year for biosimilars in the U.S. with a number of approved Humira (adalimumab) biosimilars set for staggered launches under agreements with Abbvie Inc. How successful those launches are, including the launch of Boehringer Ingelheim GmbH’s interchangeable, Cyltezo, and potential other interchangeables, will be determined in large part by three pharmacy benefit managers that together control the prescription drug formularies for nearly 80% of Americans covered by Medicare and private insurance.
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