Back in March, 2016, the Senate added language to the FDA and NIH Workforce Authorities Modernization Act which would exempt biological products, including biosimilars, from provisions of the FDCA Act that require compliance with official compendia. This language includes compliance with the quality standards listed in the United States Pharmacopeia (USP)….
Last week, IMS Health released a report entitled “The Impact of Biosimilar Competition”. The report is an update of an earlier May 2015 report that noted that biosimilar uptake could save European and American health systems up to $110 billion by 2020. The current report discusses the expected changes to…
Hetero Drugs Ltd. has announced the launch of a biosimilar for Roche’s Avastin® (bevacizumab) in India. Hetero is marketing the drug under the brand name “CizumabTM” as a treatment for metastatic colorectal cancer. Hetero’s launch is the second release of an Avastin® biosimilar in India– earlier this month, Reliance Life Sciences launched its own…
Sandoz has announced plans to expand its biosimilars offerings within the next five years, including a total of 11 filings by the end of 2017, and 5 launches by 2020. Sandoz says that its next five launches will be biosimilars to Enbrel® (etanercept), Humira® (adalimumab), Neulasta ® (pegfilgrastim), Remicade® (infliximab)…
A bill introduced in the House of Representatives yesterday proposes “[t]o amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 7 years.” Titled the “Price Relief, Innovation, and Competition for Essential Drugs Act,” or the “PRICED Act,” the proposed bill…
IPR2016-00383 (U.S. Patent No. 6,331,415) (Genzyme) (Cabilly II patent) – Denying Institution of IPR The PTAB has denied IPR on U.S. Patent No. 6,331,415. On June 8, the PTAB instituted a separate Genzyme petition against this patent (IPR20016-00460), which was joined to an earlier Sanofi-Aventis and Regeneron IPR (IPR2015-01624) based on the same grounds.
Addressing the America Invents Act proceedings for the first time, the Supreme Court’s decision in Cuozzo Speed Technologies LLC v. Lee largely maintained the status quo. The Court held that the Patent Trial and Appeal Board’s (PTAB) determination on whether to institute an inter partes review is not appealable in…
Earlier this month we reported that FDA had published a notice in the Federal Register soliciting comments on a proposed biologic naming guidance whereby applicants for biologic products would submit up to 10 proposed four-letter suffixes and, optionally, analyses supporting those suffixes. FDA has now announced that it is withdrawing…
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…