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.
As we previously reported last year, in the ongoing Janssen v. Celltrion
litigation concerning Celltrion’s Inflectra®, a biosimilar of Janssen’s Remicade® (infliximab), Janssen appealed
the district court’s partial final judgment
of invalidity of Janssen’s ’471 patent based on […]
Today, Boehringer Ingelheim received FDA approval
for Cyltezo®, its biosimilar to AbbVie’s Humira® (adalimumab). Cyltezo® is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, […]
The Australian Federal Court recently ruled that to be eligible for an extension, a patent must cover a “product” rather than a “method of use.” AbbVie Biotechnology Ltd (AbbVie) filed requests to extend Australian patents […]
Yesterday, Biogen announced
that the European Commission has granted marketing authorization for Imraldi® (also known as SB5). Imraldi® is a biosimilar for Humira® (adalimumab). Imraldi® is approved for the treatment of rheumatoid arthritis (RA), juvenile […]
On July 17, 2017, in the ongoing Amgen v. Sandoz
litigation regarding Sandoz’s proposed biosimilar of Neulasta® (pegfilgrastim), the magistrate judge ordered
, among other things, that Amgen is entitled to […]
Sandoz has filed two petitions for IPR challenging Abbvie patents related to use of an antibody identified in the petitions as Humira® (adalimumab): IPR2017-01987
challenging U.S. Patent 8,911,737, directed to methods of treating Crohn’s […]
Yesterday, Sandoz announced
the launch of its etanercept product, Erelzi®, in Canada. Erelzi is a biosimilar to Amgen’s Enbrel®, and is approved for the treatment of moderately to severely active rheumatoid arthritis in adults with or without […]
Samsung Bioepis announced
that it has entered into a Strategic Collaboration Agreement with Takeda Pharmaceutical Company to co-develop novel biologic therapies in unmet disease areas. The companies’ first therapeutic candidate is intended to treat severe acute […]
Ireland’s Department of Health (the “Department”) recently reported on its website
that it is “developing a National Biosimilar Medicines Policy to promote the use of biosimilar medicines and to create a sustainable environment for […]
As we’ve posted here
, Biocon and Mylan are jointly developing a portfolio of biosimilars, including Fulphila (Pegfilgrastim) and Ogivri (Trastuzumab), and have filed applications for marketing authorization in the European Union (EU) for those products. […]