Here are our picks of some legal developments to keep an eye out for in the new year: Etanercept biosimilar trial decision – This past September, in the Immunex v. Sandoz BPCIA patent litigation concerning Sandoz’s Erelzi™ (etanercept-szzs), an FDA-approved but yet-unmarketed biosimilar of Enbrel®, the New Jersey district court…
Here are our picks for the most significant U.S. regulatory developments related to biosimilars in 2018: 1. FDA Releases Biosimilars Action Plan In July, FDA released the Biosimilar Action Plan (BAP), which outlines the Administration’s proposed next steps to help reduce the costs of healthcare by expediting the development of…
Here are our picks for the top five most significant legal developments of 2018 that may impact the biosimilar industry: 1. New Law Requiring FTC/DOJ Review Of Biosimilar Patent Litigation Settlements With the enactment of the Patient Right to Know Drug Prices Act, biosimilar applicants and reference product sponsors must file patent…
Here are our picks for the top-five most significant foreign biosimilar market developments in 2018: 1. Shake-up In Europe’s Adalimumab Market As a result of litigation and resulting global settlements, several adalimumab biosimilars launched in Europe this year. In October 2018, Amgen, Sandoz, Samsung Bioepis and Mylan launched adalimumab biosimilars,…
Here are our picks for the top-five most significant U.S. biosimilar market developments in 2018: 1. 2018 Sets New Records for Biosimilar Approvals and Launches When 2018 began, nine biosimilars had received FDA approval, and only three were on the U.S. market. This past year saw a record-breaking seven FDA…
Below is a summary of recent updates on clinical studies involving bevacizumab and infliximab biosimilars. Bevacizumab: China-based Innovent Biologics announced last week that IBI305, a potential biosimilar to bevacizumab, met pre-defined primary endpoints in two clinical trials against branded bevacizumab. One trial was a phase III clinical trial that compared…
On December 14, 2018, Prestige Biopharma (“Prestige”) announced a partnership with Cipla Ltd. (“Cipla”) for Prestige’s HD201, a proposed trastuzumab biosimilar of Roche’s Herceptin®. Prestige’s HD201 is in Phase-3 clinical development for the treatment of patients with HER2-overexpressing breast cancer. According to the press release, under the agreement, Cipla will…
On June 13, Senator Orrin Hatch (R-UT), co-author of the Drug Price Competition and Patent Term Restoration Act (aka the “Hatch-Waxman Act”), proposed an amendment in the Senate Judiciary Committee to modify the inter partes review (IPR) process for pharmaceuticals. The amendment, titled the Hatch-Waxman Integrity Act of 2018, would require aBLA…
As has been widely reported over the past few days, the federal district court for the Northern District of Texas has issued an order declaring that the individual mandate of the Affordable Care Act (ACA, commonly referred to as “Obamacare”) is unconstitutional, that the remaining provisions of the ACA are not severable…
Today, the FDA approved Celltrion’s Herzuma (trastuzumab-pkrb), a biosimilar that references Genentech’s Herceptin (trastuzumab), for the treatment of patients with HER2-overexpressing breast cancer, in accordance with the FDA-approved label. Celltrion’s product is the subject of ongoing BPCIA litigation, pending before the District of Delaware. This marks the seventh biosimilar the FDA has approved…