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…
We have previously reported on the class action suit against AbbVie alleging misconduct and antitrust violations in connection with AbbVie’s assertion of patents to prevent the sale of biosimilar versions of Humira® in the United States. AbbVie had moved to dismiss the lawsuit. On May 15, 2020, the plaintiffs filed…
Revance Therapeutics, Mylan, and Formycon have announced updates to their biosimilar plans. In the Q1 2020 Earnings Conference Call on May 7, 2020, Revance updated investors on the biosimilar to BOTOX® program in potential partnership with Mylan. Revance informed investors that Mylan had requested additional information from Revance, and would…
Samsung Bioepis Co., Ltd. announced on Friday that the four-year follow-up data from a Phase 3 study for ONTRUZANT, a biosimilar of HERCEPTIN (trastuzumab), will be presented later this month at the ASCO20 Virtual Scientific Program. The data are from an ongoing five-year follow-up study assessing the cardiac safety and…
A new study funded by Sandoz related to the budget impact of expanding patient access to biosimilar pegfilgrastim (Ziextenzo) was presented during the Academy of Managed Care Pharmacy’s AMCP eLearning Days virtual meeting in April. The study found that expanding access to Ziextenzo to patients with intermediate risk of developing febrile…
On May 8, 2020, AbbVie announced that it completed its acquisition of Allergan plc, having received approval by the Irish High Court. AbbVie and Allergan had previously announced, on May 5, 2020, that the U.S. Federal Trade Commission accepted the proposed consent order in connection with the acquisition. As part of…
In a study published in Clinical Therapeutics on April 22, AryoGen Pharmed’s proposed bevacizumab biosimilar, BE1040V (STIVANT), was found to be noninferior to the reference product (AVASTIN) in a Phase III clinical trial in patients with metastatic colorectal cancer. AryoGen Pharmed is a pharmaceutical manufacturer based in Iran that specializes…
On May 6, 2020, Bausch + Lomb and co-development partners STADA and Xbrane announced that they have entered into an exclusive licensing agreement with one another under which Bausch + Lomb will commercialize Xlucane, STADA and Xbrane’s proposed biosimilar of LUCENTIS (ranibizumab), if approved, in the United States and Canada….
On April 30, 2020, Sanofi received a positive opinion from the European Medicines Agency (EMA)’s Committee for Medical Products for Human Use (CHMP), recommending the granting of marketing authorization for its biosimilar of insulin aspart (NovoRapid, marketed by Novo Nordisk). Insulin aspart is a fast-acting insulin analogue that is absorbed…
On April 28, 2020, the U.S. Patent and Trademark Office (USPTO) issued a notice to extend certain patent and trademark deadlines to June 1, lengthening extensions that the USPTO had announced on March 31. Pursuant to the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), certain deadlines between March…