The U.S. FDA recently approved Genentech’s Phesgo™ for the treatment of early and metastatic HER2-positive breast cancer, in combination with chemotherapy. Phesgo™ is a fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase, administered via subcutaneous injection. Fujifilm Kyowa Kirin Biologics recently announced that it received approval in Japan for its adalimumab…
On June 10, 2020, the U.S. Food and Drug Administration (FDA) approved Pfizer’s NYVEPRIA (pegfilgrastim-apgf), a biosimilar of Amgen’s NEULASTA. NYVEPRIA is indicated to “decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of…
Fresenius Kabi announced on May 27, 2020 that the FDA “accepted for review the company’s Biologics License Application (BLA) for MSB11455,” a biosimilar candidate of NEULASTA (pegfilgrastim). According to the press release, this is Fresenius Kabi’s first biosimilar candidate submitted to the FDA. Fresenius Kabi also received acceptance for review…
As we have previously reported, in February 2020 FDA and FTC announced a joint collaboration “to advance competition in the biologic marketplace.” On March 9th, the two agencies held a public workshop to discuss their “collaborative efforts to support appropriate adoption of biosimilars, discourage false or misleading statements about biosimilars, and…
Swedish biotechnology company Xbrane Biopharma reports that, despite the difficulties posed by the Covid-19 pandemic, it will continue to recruit patients for the ongoing Phase III trial of its Xlucane® (ranibizumab) biosimilar product, and that it is still on track towards regulatory approval ahead of Lucentis® patent expiration in the…
Lannett has announced that it will meet with the FDA on June 9, 2020, to “plan next steps for the clinical advancement of” its insulin glargine biosimilar product. According to the press release, “[i]nsulin glargine is a long-acting insulin used to treat adults with Type 2 diabetes, as well as…
The FDA recently issued a final rule regarding the definition of “biological product,” amending its previous definition. The statutory definition of “biological product” included “protein (except any chemically synthesized polypeptide),” but this past December Congress removed the parenthetical excluding “any chemically synthesized polypeptide.” Now, the FDA has announced that it…
Today the FDA launched a partial searchable version of the “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations”, colloquially known as the “Purple Book“. According to the FDA’s press release, the Purple Book is now available both as lists and a searchable, online database. …
The FDA issued a draft guidance today titled “Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed.” In this guidance, the FDA addresses the following issues: Submission of an application seeking licensure of a proposed biosimilar or proposed interchangeable…
Earlier this week FDA issued a draft guidance on “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products.” The draft guidance addresses the truthful and non-misleading manner in which data and information concerning reference or biosimilar products must be presented. The draft guidance does not address issues…