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.

Filgrastim, pegfilgrastim biosimilar litigation updates

Below is a rundown of some recent developments in BPCIA litigations concerning biosimilars of Neupogen® (filgrastim) and/or Neulasta® (pegfilgrastim). Amgen v. Adello (filgrastim) As we previously reported, in March, Amgen filed a complaint for patent infringement against Adello Biologics based on its filing of an aBLA for a filgrastim biosimilar. …

Read More

HHS Seeks Public Comments on Trump Administration's Plan to Lower Drug Prices

Last week the Department of Health and Human Services (HHS) issued a request for comments on the Trump administration’s plan to lower drug prices.  The HHS blueprint to lower drug prices includes improving competition by promoting innovation and competition for biologics.  According to HHS, “FDA will issue new policies to improve availability, competitiveness, and adoption of…

Read More

Apotex Proposed Merger of AUS & NZ Operations

Last week, Apotex Australia, an affiliate of the Canadian-based Apotex, Inc., announced a proposed merger of their Australian and New Zealand generic pharmaceutical and over-the-counter (OTC) operations with Arrow Pharmaceutical. This combined operation aims to offer pharmacists, patients and consumers a diverse range of almost 500 products, and permit the…

Read More

Deal Watch: Catalent Biologics and Valerius Biopharma to Collaborate on Manufacture of Specialty Biosimilar Products

  Earlier this week, Catalent Pharma Solutions and Valerius Biopharma AG jointly announced their collaboration on the manufacture of Valerius’ specialty biosimilar products.  According to the press release, Catalent Biologics will provide cell line development and support cGMP manufacturing activities from Phase I through to commercial stages.  The collaboration will…

Read More

Federal Circuit Addresses Standing in Decision on Appeal from PTAB

Last week, the Federal Circuit issued a decision in Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, in which the court held that Altaire had standing to appeal the PTAB’s final written decision in a post-grant review (“PGR”) of Paragon’s U.S. Patent No. 8,859,623 and reversed-in-part and vacated-in-part the PTAB’s Final Written Decision….

Read More

FDA accepts Coherus’s resubmitted pegfilgrastim biosimilar application

As we reported earlier this month, Coherus BioSciences recently resubmitted its application for CHS-1701, a proposed biosimilar to Neulasta® (pegfilgrastim), in response to a Complete Response Letter that it received from the FDA last June. Yesterday, Coherus announced that the FDA has accepted its pegfilgrastim resubmission and that the FDA considered…

Read More

President Trump’s Remarks on Lowering Drug Prices; Industry Reactions

On May 11, President Trump delivered remarks about his administration’s new plan to help lower drug prices.  The President blamed “soaring drug prices” on “everyone involved in the broken system,” including “the drug makers, insurance companies, distributors, pharmacy benefit managers, and many others,” such as “middlemen,” “special interests” as well…

Read More

FDA Approves Hospira's Epoetin Alfa Biosimilar (UPDATED)

For just the tenth time since the implementation of the BPCIA, the FDA has approved a biosimilar product.  Today, the FDA announced that it has approved Pfizer-subsidiary Hospira’s Retacrit™ (epoetin alfa-epbx) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV…

Read More

Q1 2018 Earnings Roundup: Biosimilars Update

Over the past few weeks, numerous biologics and biosimilar companies released their quarterly earnings for Q1 2018 and held related earnings calls.  Below are some highlights: On April 17, Johnson & Johnson (J&J) reported a 22.5% year-over-year (YOY) decline in U.S. sales of Remicade® (infliximab), which it attributed “to increased discounts/rebates,…

Read More

Global Biosimilar Development Updates

Over the past week, biopharmaceutical developers from around the world provided updates on the development and availability of a number of biosimilar products and candidates.  Below are some highlights. On May 2, Mundipharma, a global network of independent associated companies, announced that the trastuzumab biosimilar Herzuma® is now available in…

Read More