We have covered Pfizer’s development of biosimilars of Genentech’s Avastin® (bevacizumab) and Herceptin® (trastuzumab) and its related IPR filings IPR2016-01771 and IPR2016-01837. Following written decisions invalidating those two patents, Genentech appealed and challenged the constitutionality of subjecting patents that issued before the America Invents Act (AIA) was enacted in 2011…
Last week the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) recommended two biosimilar medicines for approval. First, the CHMP adopted a positive opinion for the marketing authorization of Kanjinti® (ABP 980), Amgen and Allergan’s proposed biosimilar to Herceptin® (trastuzumab). The CHMP opinion recommends…
Sources are reporting that Korean pharmaceutical company Daewoong Pharmaceutical announced today that it has launched Samfenet, a biosimilar to Roche’s HERCEPTIN® (trastuzumab), in Korea. Samfenet is priced at a 29.5-percent discount to Herceptin, which amassed around $6.5 billion in global revenue last year. Mylan announced last week that it has…
Yesterday, Samsung Bioepis announced that the FDA has accepted for review the company’s BLA under the 351(k) pathway for SB3, a biosimilar candidate referencing Genentech’s Herceptin® (trastuzumab). The press release states that this is Samsung Bioepis’ first submission for FDA-approval of an oncology biosimilar candidate. According to the press release,…