On March 17, 2021, Merck announced that it had filed a Form 10 registration statement with the U.S. Securities and Exchange Commission in order to spinoff its women’s health, biosimilars and established brands businesses into a standalone, publicly traded company, named Organon. Merck explained that Organon’s vision is to “create…
On March 10, Lannett announced that it received feedback from the FDA regarding its insulin glargine biosimilar. Lannett sought and received comments from the FDA concerning the protocol and statistical analysis plan to be used in the pivotal clinical trial for the product. Lannett reported that it incorporated this feedback…
On March 1, 2021, the Supreme Court heard oral argument on Arthrex and the constitutionality of IPRs. Listen here for insightful analysis of the arguments from our Supreme Court and IPR experts, William Jay, David Zimmer, and Linnea Cipriano.
As regular Big Molecule Watch readers know, the Biologics Price Competition and Innovation Act (“BPCIA”) was signed into law as part of the Affordable Care Act on March 23, 2010, creating an abbreviated licensure pathway for “biosimilar” and “interchangeable” biological products. The BPCIA also introduced a new scheme to resolve…
Celltrion Inc. has begun a Phase 3 clinical trial of CT-P42, an aflibercept biosimilar referencing Regeneron’s Eylea. The trial will enroll 300 patients with diabetic macular edema, and aims to compare CT-P42’s efficacy, safety, pharmacokinetics, and immunogenicity against Eylea. Celltrion adds CT-P42 to its pipeline of other investigational biosimilars, including…
As described below, Adocia, Cue Biopharma, and Eucure Biopharma each recently announced clinical updates with regards to their biologic product candidates or combination therapies. Adocia, a clinical-stage biotechnology company headquartered in France, reported positive results from a clinical pharmacology study using its proprietary BioChaperone® (BC) ultra-rapid prandial insulin formulation. The study…
Below are some highlights from fourth quarter and full year 2020 earnings reports recently released by biologics and biosimilars companies: At the end of last month, Johnson & Johnson reported fourth quarter sales of $22.5 billion reflecting growth of 8.3% and full year sales of $82.6 billion reflecting growth of…
At its January meeting last week, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended approval for two biosimilar bevacizumab medicines, Alymsys and Oyavas. Mabxience Research SL’s Alymsys and STADA Arzneimittel AG’s Oyavas both received positive opinions for the treatment of carcinoma of the colon or rectum, breast cancer, non-small…
On January 28, 2021, Bio-Thera Solutions announced that the Food and Drug Administration (FDA) accepted its Biologics License Application (BLA) for BAT1706, a proposed biosimilar to Avastin® (bevacizumab). The BLA seeks approval of BAT1706 for the treatment of diseases for which the US-licensed Avastin is approved, including metastatic colorectal cancer…
We have concluded our webinar series relating to Goodwin’s Guide to Biosimilars Litigation and Regulation in the U.S., which provides expert guidance and practical know-how for lawyers working in this growing area of the law. This webinar series provided an opportunity to dive deep into some of the key topics…