Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Drug Pricing Initiatives During the Trump Presidency
A changing competitive landscape: the role of the ITC in the biosimilars space
Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
Insulin Glargine Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
Last week Pfizer filed a lawsuit in a federal court of Australia against respondents Samsung Bioepis, Merck, Sharp & Dohme, Organon, and Arrow, to halt sales of their biosimilar BRENZYS (etanercept). Pfizer alleges that the...more
On March 17, 2021, Merck announced that it had filed a Form 10 registration statement with the U.S. Securities and Exchange Commission in order to spinoff its women’s health, biosimilars and established brands businesses into...more
As we ring in the new year, we look back at the top U.S. biosimilar market developments of 2020. Here are some of our highlights, in no particular order...more
On September 15, 2020, Merck Canada Inc., an affiliate of Merck & Co., Inc., announced that Health Canada approved BRENZYS® (etanercept) for the following additional indications...more
On Wednesday, Samsung Bioepis and Merck announced the U.S. launch of Ontruzant® (trastuzumab-dttb), a biosimilar to Herceptin® (trastuzumab). Ontruzant® is indicated for the treatment of HER2-overexpressing breast cancer,...more
Last week, Merck announced its intention to spin-off products from its Women’s Health, legacy brands, and biosimilars businesses into a new, yet-to-be-named, independent, publicly traded company. According to Merck, “NewCo...more
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...more
Last week it was reported (here and here) that Merck launched Samsung Bioepis’ Ontruzant® in the United Kingdom, the first biosimilar trastuzumab launched in Europe. Ontruzant® is a biosimilar of Roche’s Herceptin® and is...more
The Journal of Clinical Oncology reported that Merck and Samsung Bioepis’ biosimilar to trastuzumab (Herceptin®), SB3, demonstrated equivalence to trastuzumab in recent Phase III trials. According to the report, in a phase...more
Here are our picks for the top-5 biggest deals in the world of biosimilars in 2017...more
Last week Fresenius Kabi announced that it has successfully closed its acquisition of Merck KGaA’s biosimilars business, which comprises Merck’s entire biosimilars development pipeline. According to Fresenius, the product...more
Merck & Co. and Samsung Bioepis announced today the U.S. launch of Renflexis (infliximab), a biosimilar of Janssen’s Remicade. Renflexis was approved on April 21 by the FDA for all eligible indications. ...more
The Competition and Markets Authority (CMA) in the United Kingdom announced a provisional decision finding that Merck Sharp & Dohme (MSD) violated competition law with its discount pricing on Remicade. This provisional...more
On Monday, April 24, 2017, Fresenius Kabi and Merck KGaA announced that Fresenius will be acquiring Merck KGaA’s biosimilars business. According to Merck KGaA’s press release, Merck KGaA’s biosimilar portfolio focuses on...more
Six years after the biosimilar pathway was enacted into law, FDA has approved three biosimilars for marketing in the US. Sandoz’s Zarxio, a biosimilar of Amgen’s Neupogen, was the first biosimilar to be approved. Zarxio, a...more
We recently posted that Merck had announced “promising” results from Phase III studies evaluating MK-1293, an investigational follow-on biologic insulin glargine candidate for the treatment of people with type 1 and type 2...more
On July 22, 2016, Australia’s Therapeutic Goods Administration approved Samsung Bioepis’s biosimilar of Amgen’s Enbrel (etanercept), which is approved for treatment of rheumatoid arthritis. Samsung Bioepis’s product, called...more
180-Day Notice Period for Biosimilar Approval Is Always Mandatory and Enforceable by Injunction - Amgen Inc., v. Apotex Inc., (Fed. Cir. July 5, 2016) - A year after analyzing the patent dance and notice...more
Merck, known as MSD outside the United States and Canada, announced promising results from two Phase III studies evaluating MK-1293 – Merck’s biosimilar to Lantus (insulin glargine). Lantus is used for the treatment of...more
Remsima, a biosimilar of Remicade (infliximab), was granted a marketing authorization throughout the European Union in 2013. Earlier this week, Merck reported a 30% drop in Remicade first-quarter sales due to “the...more