As we previously reported, late last year the Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Industry Organization (BIO) trade associations jointly submitted a Citizen Petition asking the FDA to impose stricter labeling requirements on biosimilar applicants. Last month, the Generic Pharmaceutical Association (GPhA) submitted a comment in opposition…
As we posted earlier this morning, the Supreme Court has invited the Solicitor General to file briefs regarding the Sandoz v. Amgen and Amgen v. Sandoz petitions for certiorari. Below we provide further analysis and commentary on the announcement, and an overview of what we can expect next. Analysis The Court’s move indicates a substantial degree of…
The Supreme Court today invited the Solicitor General to file briefs regarding the Sandoz v. Amgen and Amgen v. Sandoz petitions for certiorari–see page two of today’s order list: https://www.supremecourt.gov/orders/courtorders/062016zor_e2q3.pdf. See our post here for recent coverage on the petitions, and stay tuned for further updates.
In the ongoing litigation over infliximab biosimilars, Janssen has filed two new complaints alleging infringement of claims in U.S. Patent No. 7,598,083: one against Celltrion and Hospira, and a second against HyClone Laboratories, Celltrion’s Utah-based supplier of cell culture media. These complaints follow Judge Wolf’s recent order in Janssen’s original…
Merck, known as MSD outside the United States and Canada, announced promising results from two Phase III studies evaluating MK-1293 – Merck’s biosimilar to Lantus (insulin glargine). Lantus is used for the treatment of people with type 1 and type 2 diabetes. In both Phase III studies, MK-1293 demonstrated statistical…
According to the Korea Pharmaceutical Manufacturers Association, the biosimilars market in South Korea will grow to 150 billion won (~$130 million) by 2019, nearly doubling in size from its 2013 value. Six biosimilars have been approved in South Korea since 2012, and dozens of other biosimilars are currently in the development…
As we previously reported, on February 16, 2016, Sandoz petitioned the United States Supreme Court for a writ of certiorari regarding the Federal Circuit’s interpretation of the BPCIA’s “notice of commercial marketing” provision—subsection (l)(8)(A)—as authorizing such notice only after FDA approval of an aBLA. In response, on March 21, Amgen…
Yesterday, the Federal Circuit issued a final decision in Genzyme Therapeutic Prods. v. Biomarin Pharms., No. 2015-1720 case affirming two PTAB IPR final decisions invalidating as obvious the claims of U.S. Patent Nos. 7,351,410 and 7,655,226, which are directed to the treatment of Pompe’s disease with injections of human acid…
Yesterday, the PTAB instituted IPRs on two of Abbvie’s Humira patents, U.S. Patent Nos. 9,017,680 and 9,073,987, which are drawn to dosing regimens for AbbVie’s Humira (adalimumab) for the treatment of rheumatoid arthritis. As previously reported here, the PTAB previously instituted an IPR on related U.S. Patent 8,889,135 based on a petition…
At the Annual European Congress on Rheumatology (EULAR 2016), held last week in London, Samsung Bioepis presented new clinical data on its etanercept, adalimumab, and infliximab biosimilars. According to a press release from Biogen, a partner in the Samsung Bioepis joint venture with Samsung BioLogics, Phase III studies for those anti-TNF-α biosimilars have demonstrated that…