According to an April 2024 press release, Alvotech and Teva’s Selarsdi™ (ustekinumab-aekn) was approved by the FDA on April 16 as a biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab). ...more
On April 16, Alvotech and Teva announced the FDA approval of SELARSDI™ (ustekinumab-aekn), biosimilar to Johnson and Johnson’s STELERA® (ustekinumab)....more
The Federal Trade Commission (“FTC”) has filed an amicus brief in Teva Branded Pharmaceuticals Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC to further the agency’s efforts to promote and protect generic drug...more
On August 7, 2023, Formycon AG and Fresenius Kabi announced that they have reached a settlement with Johnson & Johnson (“J&J”) in the United States relating to FYB202, a proposed ustekinumab biosimilar to STELARA®, marketed...more
Alvotech and Teva announced an expansion of their existing strategic partnership agreement relating to biosimilars products in the U.S. According to the announcement, the existing agreement includes AVT02, an...more
Teva announced today that the European Commission has granted marketing authorization for RANIVISIO, a biosimilar ranibizumab, for the treatment of age-related macular degeneration (AMD). Teva entered into a strategic...more
Earlier this week, Teva Pharmaceutical Industries Ltd. (Teva) announced that the UK Medicines & Healthcare Regulatory Agency (MHRA) approved ONGAVIA, a ranibizumab biosimilar referencing Genentech’s LUCENTIS. Ranibizumab...more
Below are some highlights from first quarter 2022 earnings reports recently released by biologics and biosimilars companies: Biogen: Last week, Biogen reported total quarterly revenues of $2,532 million, and biosimilar...more
As noted in our December 21, 2021 post, Complainants AbbVie Inc., AbbVie Biotechnology Ltd. and AbbVie Operations Singapore Pte. Ltd. filed a complaint at the International Trade Commission against Respondents Alvotech hf.,...more
Skinny labels are back in focus at the White House. On September 9, 2021, the U.S. Department of Health and Human Services submitted its much-anticipated report to the White House Competition Counsel regarding a...more
On August 5, 2021, the Federal Circuit withdrew its October 2020 opinion in GSK v. Teva, summarized in this post on induced infringement of method-of-treatment claims, and issued an opinion that reiterated the prior holding...more
This week, three development programs announced updates to their ranibizumab biosimilars. Ranibizumab is the active ingredient in Genentech’s LUCENTIS, which is indicated for retinal vascular disorders, including neovascular...more
In December 2020, the U.S. District Court for the District of Columbia issued a decision in Teva v. FDA, reviewing FDA’s definition of “protein” in connection with the agency’s determination that Teva’s Copaxone®, a...more
In GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., the Federal Circuit reinstated a jury's verdict that Teva infringed GSK's patented method of using its Coreg® drug product, even though Teva's product was initially...more
Pharmaceutical companies Teva Pharmaceutical Industries Ltd. and Alvotech announced on Wednesday, August 5, 2020, that they will be entering into an exclusive partnership for the commercialization of biosimilar products in...more
Today Alvotech and Teva announced that they have entered into an exclusive strategic partnership for the commercialization of five biosimilar candidates in the U.S. Under the partnership agreement, Alvotech will be...more
Teva and Celltrion Healthcare announced today the U.S. launch of TRUXIMA® (rituximab-abbs) for rheumatoid arthritis (RA). TRUXIMA®, which originally launched in November 2019, is now approved to treat RA, non-Hodgkin lymphoma...more
The 10th anniversary of the U.S. biosimilar pathway the Biologics Price Competition and Innovation Act of 2009 (BPCIA) is quickly approaching and marks an expansion of the U.S. biosimilar market. The BPCIA, signed into law...more
Teva and Celltrion announced yesterday that their HERZUMA (trastuzumab-pkrb) for Injection, a biosimilar to HERCEPTIN, was available in the U.S. The biosimilar has the same indications as the reference product, and will be...more
As we start the new year, we look back at the top U.S. biosimilar market developments of 2019. Here are some of our highlights, in no particular order...more
On November 7, Teva Pharmaceuticals USA, Inc., and Celltrion, Inc., announced that TRUXIMA® (rituximab-abbs) will be available in the United States beginning November 11. As we previously reported, TRUXIMA® is the first...more
Federal Court of Appeal requires PMPRB to re-determine whether patent ‘pertains to’ Galderma’s DIFFERIN - On June 28, 2019, the Federal Court of Appeal granted the appeal of the Patented Medicine Prices Review Board (PMPRB...more
In 2018 we reported on a number of developments in life sciences IP and regulatory law. Our most-read articles were: #1 a June update on biosimilars (authored by Urszula Wojtyra); #2 a “live” summary chart of Vanessa’s Law...more
In This Issue: Ontario Court of Appeal allows Sanofi and Schering to plead that Federal Court ramipril patent invalidity decision was flawed due to “promise doctrine” - In an action by Apotex for compensation from...more
In this special mid-year edition, we take a look at the major highlights in Canadian life sciences and intellectual property law that we have reported on over the last six months, starting with one of the most closely-watched...more