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.
Goodwin and the Big Molecule Watch team are looking forward to participating in the 36th Annual J.P. Morgan Healthcare Conference, bringing together industry leaders from across the country. If you are planning to attend the […]
On December 29, Mylan and Biocon announced
that their trastuzumab biosimilar, Zedora, was approved by Brazil’s National Sanitary Surveillance Agency. Zedora, a biosimilar of Genentech and Roche’s Herceptin, is indicated for the […]
Here are our picks for the top-5 biggest deals in the world of biosimilars in 2017: 5. Companies developing biosimilar products continue to establish partnerships to market and distribute the products on a regional basis. […]
Here are our picks for the top-five most significant legal developments regarding biosimilars in 2017: 5. In January 2017, the FDA released a draft guidance
on biosimilar interchangeability, entitled “Considerations in Demonstrating Interchangeability With a […]
Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2017: 1. Compared to three approvals in 2016, the FDA approved
five biosimilar products in 2017: Renflexis® (infliximab-abda) […]
Here are our picks for the top-five most significant foreign market developments in the world of biosimilars in 2017: The European, Latin American, and Asian markets are thriving with biosimilar applications and approvals. For example, […]
In response to an FDA request for comments regarding existing requirements for biologics and biosimilars, the American College of Rheumatology (ACR) submitted a letter identifying six “minimum components of review and oversight.” The FDA’s request […]
We previously reported
that on September 12, 2017, the FDA accepted for review Sandoz’s aBLA for a proposed biosimilar of Rituxan® (rituximab), which is indicated for the treatment of certain blood cancers and immunological diseases. Yesterday, Genentech […]
As we previously reported
, last month a Federal Circuit panel affirmed the district court’s judgment
that Apotex’s pegfilgrastim and filgrastim biosimilar candidates do not infringe Amgen’s protein refolding method patent. Amgen’s time for […]
Yesterday, Samsung Bioepis announced
that the FDA has accepted for review the company’s BLA under the 351(k) pathway for SB3, a biosimilar candidate referencing Genentech’s Herceptin® (trastuzumab). The press release states that this is […]