Welcome to the Big Molecule Watch!

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Big Molecule Watch will be posting updates and analyses on regulatory issues, litigation, legislation, and other news in the ever-developing world of biosimilars. The editors of this blog have collectively been watching and engaging with the world of biosimilars (“big molecules”) since before the inception of the biosimilar industry in the U.S., and we’re excited to share the observations of our active watch on this new forum.

If you’re looking for a primer on biologics, check out our background post introducing the world of biologics, biosimilars, and the Biologics Price Competition and Innovation Act (“BPCIA”).

We’ve also collected (and will continue to update) some reference documents that might be of interest to visitors of this blog—you can find them under the “Links” section to the right of this page.

Sandoz Announces Plans to Expand its Biosimilars Offerings

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)…

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Legislation Tracker: PRICED Act Proposes to Shorten Biologic Exclusivity Period from 12 to 7 Years

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…

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IPR Tracker: IPR2016-00383 (U.S. Patent No. 6,331,415) (Genzyme) (Cabilly II patent) - Denying Institution of IPR

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.

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FDA Issues Interim Response to PhRMA/BIO Joint Citizen Petition on Biosimilar Labeling

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…

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Janssen Sues HyClone Laboratories Over Cell Cultures Used to Grow Celltrion’s Remicade Biosimilar

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…

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Merck's Lantus Biosimilar Queued for an FDA Submission?

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…

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