On February 5, 2019, Mundipharma announced the European launch of Pelmeg® (pegfilgrastim), a biosimilar of Neulasta®. As we have previously reported, Mundipharma acquired Pelmeg® from Cinfa Biotech and it was approved by the European Commission in November 2018. According to the press release, Pelmeg® is now available in Germany, the…
Below are some recent updates regarding biosimilar pipelines from around the globe. On November 2, 2018, Sandoz announced that it has decided “not [to] pursue its submission for biosimilar rituximab in the US at this time … follow[ing] a request by the US Food and Drug Administration (FDA) for additional…
In August, we reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the granting of marketing authorization for three biosimilar medicines: (1) Fujifilm Kyowa Kirin Biologics (FKB) and Mylan’s Hulio® (adalimumab), a proposed biosimilar of Humira®; (2) Accord Healthcare’s Pelgraz® (pegfilgrastim),…
Below is a roundup of several recently published comparative studies between biosimilars and reference biologics. In a study presented at the American Society of Hematology’s 59th Annual meeting, the authors concluded that there were no clinically meaningful differences in the safety profile of Cinfa Biotech’s B12019 biosimilar to Neulasta® (pegfilgrastim) compared with…
Below are regulatory and development updates regarding a number of biosimilar candidates. Today, Amgen and Allergen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorization of ABP 215, their proposed biosimilar of Avastin®…
Last week, Cinfa Biotech S.L. announced that the European Medicines Agency (EMA) has accepted its application to market a molecule referred to as B12019, a biosimilar of Amgen’s Neulasta® (pegfilgrastim), for the treatment of chemotherapy-induced neutropenia. To support its application, Cinfa conducted two studies confirming the analytical and biofunctional similarity…
Cinfa Biotech, a Spanish company focusing on the development of biosimilars, announced positive results from their second clinical trial evaluating a biosimilar version of Amgen’s Neulasta (pegfilgrastim). According to the company’s press release, the trial demonstrates that Cinfa Biotech’s biosimilar is comparable to Amgen’s Neulasta in terms of pharmacodynamics, immunogenicity, and…