Welcome to the Big Molecule Watch!

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.

Agency Activity During Government Shutdown

As the government shutdown continues, administrative agencies have been updating the public on their operating status. The FDA has released a statement on its website explaining that its operations will “continue to the extent permitted by law, such as activities necessary to address imminent threats to the safety of human…

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FDA Says It Will “Take Action” Against Companies Creating Confusion About Biosimilar Safety

In a tweet today, FDA Commissioner Scott Gottlieb stated:  “FDA continues to be concerned about branded companies creating confusion about the safety and effectiveness of biosimilars and we’ll take action if we determine a company is deliberately misleading the public about the safety of these important products.”  The communication comes in response…

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Goodwin Presents on Practical Considerations for Foreign Developers Launching a Biosimilar in the US at JP Morgan Healthcare Conference

Goodwin and the Big Molecule Watch team are looking forward to participating in the 37th Annual JP Morgan Healthcare Conference, bringing together industry leaders from across the country. If you are at the conference in San Francisco, we hope you will join the team today, January 9, 2019 for our…

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Coherus Biosciences Launches UDENYCA (pegfilgrastim-cbqv), and Secures $75 Million Credit Financing to Accelerate Manufacture and Sale

Coherus Biosciences announced today that it has entered into a $75 million senior secured credit facility agreement with Healthcare Royalty Partners.  According to the press release, the funds will be used to “accelerate and enhance the manufacture and sale of UDENYCA (pegfilgrastim-cbqv).”  The press release also confirms that UDENYCA launched…

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Kashiv Pharma Acquires Adello Biologics and Becomes Kashiv BioSciences

Yesterday, Kashiv Pharma, LLC announced its acquisition of the assets of Adello Biologics, LLC, a biotechnology company developing biosimilars.  Kashiv will now be known as Kashiv BioSciences, LLC with its headquarters in Bridgewater, New Jersey.  It also has research and development and manufacturing facilities in Bridgewater, New Jersey, Piscataway, New…

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