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.

Oversight Committee Launches “Sweeping Drug Price Investigation” Regarding Biologics

On Jan. 14, Rep. Elijah E. Cummings, the Chairman of the Committee on Oversight and Reform, issued a press release that his office had sent letters to 12 drug companies seeking “detailed information and documents about the companies’ pricing practices,”  including material regarding price increases, investments in research and development,…

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Tanvex’s New Drug Submission for Filgrastim Biosimilar to Health Canada

BioSimilars Patent Dance

Last October, we reported that Taiwan-based Tanvex BioPharma (“Tanvex”) announced that it had submitted a BLA to the FDA seeking approval of TX-01, a proposed biosimilar referencing Neupogen® (filgrastim) indicated for chemotherapy induced neutropenia. Last November, the FDA accepted Tanvex’s BLA for its filgrastim biosimilar. This week Tanvex has submitted a New Drug Submission (NDS) to…

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Alvotech Raises US$300 Million To Boost Biosimilar Pipeline

Alvotech announced today that its current product pipeline of “six biosimilar monoclonal antibodies aimed at treating cancer, autoimmune, inflammatory and other diseases” will receive an injection of capital from funds raised through a private bond offering. Having raised US$300 million, Alvotech plan to use the net proceeds “to fuel continued…

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FDA Approves Samsung Bioepis’s Trastuzumab Biosimilar

Today, the FDA approved Samsung Bioepis’s Ontruzant (trastuzumab-dttb), a biosimilar to Genentech’s Herceptin (trastuzumab), for the treatment of patients with HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.  Samsung Bioepis’s product is the subject of ongoing BPCIA litigation, pending before the District of Delaware. This is the third biosimilar…

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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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