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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 invalid, unenforceable, and not infringed.  In the decision, the court decided two significant issues of BPCIA procedure.  First, the court held that a biosimilar…
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 patent”), directed at methods of protein purification.  The complaint alleges that the parties agreed that the ’707 Patent would be the subject of an…
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) franchise and fueled by its leading contraceptive and fertility businesses.”  Merck also states that “NewCo expects to establish a leading position in Biosimilars along with…
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 Allergan’s Botox® (onabotulinumtoxinA injection).  Daewoong manufactures Jeuveau® in South Korea.  Allergan and Medytox alleged that Daewoong misappropriated Medytox’s trade secrets related to the bacterial strain…
The FDA issued a draft guidance today titled “Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed.”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 biosimilar for fewer than all of the reference product’s licensed conditions of use. Development of proposed labeling when the applicant seeks licensure of…
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 adopted a commercial strategy aimed at eliminating competition and delaying the entry of biosimilars to MABTHERA (rituximab) and HERCEPTIN (trastuzumab).  The Competition Council estimated that…
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 “[r]esults of the study will be presented in full at a future medical meeting or summarized in [a] publication.” Pfizer announced that its RUXIENCE (rituximab)…
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 unique to interchangeable biosimilars. The draft guidance addresses the “general requirements for the content of FDA-regulated promotional materials for reference products and biosimilars products.” This…
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 biosimilars within their respective authorities and deter anti-competitive behavior in this space.” The Statement identifies four joint goals to help in this effort: FDA and…
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 the Federal Circuit seeking to overturn the district court’s denial of Genentech’s motion to enjoin the U.S. marketing of MVASI (bevacizumab-awwb), a biosimilar of AVASTIN. …