In Case You Missed It: Biosimilar Market and Regulatory Updates

During the period leading up to the holidays, a number of biosimilar developers announced updates regarding their biosimilar pipelines.

On December 5, Pfizer notified the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) of its wish to withdraw its application for marketing authorization for Fyzoclad (adalimumab), due to “a change in Pfizer’s strategy.”

On December 14, Pfizer announced that the CHMP recommended marketing authorization for ZIRABEV, its potential oncology biosimilar to Avastin (bevacizumab).

On December 17, NeuClone announced that it was developing a biosimilar of Perjeta® (pertuzumab), in partnership with Serum Institute of India.

Also on December 17, Alvotech announced that Fuji Pharma had acquired a 4.2% stake in Alvotech for approximately $50 million USD, which follows the news from the previous month that the companies had entered into an exclusive partnership through which Fuji Pharma will commercialize Alvotech’s biosimilar portfolio in Japan.

On December 19, Biocon announced that the European Commission had granted marketing authorization for its and Mylan’s trastuzumab biosimilar, Ogivri®, following a positive recommendation from CHMP a few months earlier.

Also on December 19, Xbrane Biopharma announced that it had submitted an application to the FDA for the start of a clinical trial of its ranibizumab biosimilar candidate, Xlucane.

Also on December 19, Sandoz announced that it entered into a commercialization and supply agreement with Gan & Lee for the marketing of insulin biosimilars.  According to the press release, “Sandoz will be fully responsible for commercializing these medicines in the EU, US, Switzerland, Japan, South Korea, Canada, Australia and New Zealand,” and “Gan & Lee will be responsible for manufacturing and development, with support from Sandoz, and shall adhere to the stringent manufacturing requirements established for Sandoz biosimilars.”

On December 24, Mycenax announced positive Phase 1 Data for its tocilizumab biosimilar candidate, LusiNEX.

On December 27, JHL Biotech announced that the first patient has been successfully randomized in the Phase III study of its rituximab biosimilar candidate, JHL1101, to treat diffuse large B-cell lymphoma.