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New prediction methodology for calculating biosimilar application fees will help the FDA cover its costs and respond quickly to changes in demand, officials said at a public meeting.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended Samsung Bioepis’ bevacizumab biosimilar for the treatment of multiple types of cancer.

Republican opponents of the Affordable Care Act (ACA), led by the state of Texas, fired opening salvos in the Supreme Court case over the landmark law's constitutionality. If the entire law is thrown out, approval for biosimilars under the Biologics Price Competition and Innovation Act (BPCIA) would disappear, too.

HLX14, a denosumab biosimilar targeted for the treatment of postmenopausal osteoporosis in patients with a high risk of fractures, was approved by China’s National Medical Products Administration (NMPA).

Investigators found that manufacturers appear to be exploiting orphan drug exclusivities to extend market dominance and keep generics and biosimilars at bay.

This spring, The Center for Biosimilars® interviewed a variety of thought leaders for their opinions on the US biosimilar market so far in 2020 and the barriers that need to be addressed. Here are some highlights.

The judge in the Humira case, while noting that the patents have made it nearly impossible for rivals to gain a foothold, said the suit did not constitute a valid antitrust claim.

Innovent Biologics said China’s National Medical Products Administration (NMPA) has approved its biosimilar bevacizumab, Byvasda, for use in patients with lung and colorectal cancers.

The United States–Mexico–Canada Agreement came to a rocky impasse over drug exclusivity protections, and July 1 is the day this agreement takes effect.

Lannett’s insulin glargine biosimilar candidate will break new ground as it moves through the 351(k) review pathway, according to Ha Kung Wong, an intellectual property law attorney with Venable of New York.

Longtime generics maker Lannett, of Philadelphia, Pennsylvania, said an FDA meeting this week was positive for its pending insulin glargine biosimilar application.

The FDA has approved Pfizer’s pegfilgrastim biosimilar Nyvepria for use in lowering the incidence of infection as manifested by febrile neutropenia.

Although the coronavirus disease 2019 pandemic continues to hamper the pharmaceutical industry, it hasn’t stopped companies from continuing to make deals, seek approvals, and conclude clinical trials.

A study of coverage decisions by some of the nation’s largest payers indicates biosimilars get preferred status just 14% of the time.

In July 2020 Canada will implement a series of reforms to help bring runaway drug prices under control, panelists said at Virtual ISPOR 2020, the annual meeting of the International Society for Pharmacoeconomics and Outcomes Research.

The alternative payment model (APM) doesn’t perfectly balance the competing interests of revenue growth and value-based care, but it has been a learning tool, panelists said at Virtual ISPOR 2020, the annual meeting of the International Society for Pharmacoeconomics and Outcomes Research.

German biopharmaceutical company Formycon has postponed its annual meeting due to the coronavirus disease 2019 (COVID-19) pandemic.

Coherus Biosciences, of Redwood City, California, sees continued profitability, thanks largely to sales of its pegfilgrastim biosimilar, Udenyca, launched in January 2019.

Bausch + Lomb has secured the rights to commercialize a ranibizumab biosimilar in the United States and Canada.

Interest in tocilizumab has grown lately as Roche has a clinical trial underway to evaluate efficacy in coronavirus disease 2019 (COVID-19)–related pneumonia.

Although Pfizer has offered a more attractive discount for its rituximab biosimilar, Teva Pharmaceutical Industries and Celltrion Healthcare have decided not to match that discount for their own rituximab biosimilar, which is more costly.

Amgen saw biosimilar competition eat a larger share of its innovator drug revenue but also earned some biosimilar pocket money of its own.

The Committee for Medicinal Products for Human Use (CHMP) has given its recommendation for the marketing authorization of Insulin aspart Sanofi.

Here are the top 5 biosimilars articles for the week of April 27, 2020.

Trying to carve back its market share for Neupogen, its filgrastim originator product, Amgen is hoping product exclusivity can be backdated.

Pfizer is battling biosimilar competition as its brands lose exclusivity but it is fighting fire with fire, launching multiple biosimilars of its own. Biogen has extended its commercialization agreements for biosimilars and said its earnings picture improved in the first quarter of 2020.

European investigators say their analysis of court cases involving innovator monoclonal antibodies suggests secondary patents have generally failed to stop biosimilar competition.

With a growing portfolio of biosimilars, Novartis saw a 31% increase in biopharmaceutical sales for the first quarter of 2020, despite the pandemic.

Taking an abundance of time to file a motion to block Kanjinti from coming to market, Genentech unwittingly may have tipped the scales in favor of biosimilar applicants.

Henlius Biotech said its manufacturing facility has met European standards for production of its trastuzumab biosimilar candidate, which the company said is "a passport" for potential commericialization across the globe.