On February 11, 2020, in the Biogen v. Amgen BPCIA litigation regarding MVASI (bevacizumab-awwb), Amgen’s biosimilar of AVASTIN, Judge Colm Connolly of the Delaware District Court denied most of Genentech’s motion to dismiss Amgen’s affirmative defenses and counterclaims. Amgen had pled counterclaims seeking declaratory judgments that the asserted patents are…
On February 11, 2020 Amgen sued Pfizer and its affiliate Hospira for patent infringement based on their proposed biosimilar of NEULASTA (pegfilgrastim). Pegfilgrastim is indicated for decreasing the incidence of infection in patients receiving myelosuppressive chemotherapy. In the complaint, Amgen alleges that Hospira’s aBLA infringes U.S. Patent No. 8,273,707 (“the ’707…
Last week, Merck announced its intention to spin-off products from its Women’s Health, legacy brands, and biosimilars businesses into a new, yet-to-be-named, independent, publicly traded company. According to Merck, “NewCo will pursue global leadership and focused, sustainable growth in Women’s Health led by the growing and patent-protected NEXPLANON (etonogestrel implant)…
Last week a trial was held before the International Trade Commission (ITC) in the trade secret case brought by Allergan and Medytox against Daewoong and Evolus. Allergan and Medytox filed a complaint with the ITC on January 30, 2019, seeking to block importation of Jeuveau® (prabotulinumtoxinA-xvfs), Evolus’s follow-on biologic to…
The FDA issued a draft guidance today titled “Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed.”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…
On January 15, 2020, the Romanian Competition Council fined fined Roche Romania SRL €12.9 million ($14.2 million) following two investigations into what the Competition Counsel found to be Roche’s anti-competitive practices related to its cancer drugs. In the first investigation, the Competition Council found that between 2017 and 2019 Roche…
Below are a few biosimilar-related updates from the past week. Bio-Thera Solutions announced that in a Phase III clinical trial of BAT1706 (bevacizumab), BAT1706 met its primary endpoint, demonstrating “equivalence in overall response rate (ORR) for the first-line treatment of patients with non-squamous non-small cell lung cancer.” Bio-Thera indicated that…
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…
The U.S. Food and Drug Administration and the Federal Trade Commission today released a joint statement regarding collaboration to advance competition in the market for biologic products. According to the FDA press release, “[t]his joint statement describes key steps the agencies will take to address false or misleading promotion about…
Below we provide an update on some recent developments from several biosimilar-related cases on appeal before the Federal Circuit. Genentech v. Immunex Rhode Island, Fed. Cir. Case No. 19-2155 – briefing complete in bevacizumab preliminary injunction appeal On January 21, Genentech filed a reply brief in its appeal to…