Being ten years in since the enactment of the BPCIA provides us a great opportunity to take a look back at how things have developed in the world of biosimilar over the years. When we founded the Big Molecule Watch blog nearly five years ago, there was not a single…
Today, March 23, 2020, marks ten years since President Barack Obama signed the Biologics Price Competition and Innovation Act (BPCIA) into law as part of the Affordable Care Act. The BPCIA—whose legislation certain members of the Big Molecule Watch team were involved in drafting—created an abbreviated regulatory pathway for seeking…
The COVID-19 pandemic has introduced new challenges for the pharmaceutical industry, including makers of biosimilars. In response, the FDA has asked pharmaceutical makers to closely monitor their supply chains and highlighted some of the ways the coronavirus could impact developmental pipelines. While the risk of supply chain disruptions is uncertain,…
Mylan announced on its most recent quarterly earnings call that it expects to launch its rituximab and etanercept biosimilars in Europe later this year. In discussing Mylan’s biosimilars pipeline, Rajiv Malik, Mylan’s President, told market analysts, “we also have for Europe rituximab and Enbrel biosimilars, which will be most likely…
The Federal Circuit has declined to reconsider its December 2019 affirmance of the district court ruling in the Amgen v. Hospira (epoetin alfa) dispute. As we have previously reported, that ruling upheld a jury verdict finding (among other things) that Hospira’s manufacture of certain drug substance batches was not protected…
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 priced at a Wholesale Acquisition Cost (“WAC”) that is a 10% discount to the WAC of HERCEPTIN. …
As we previously reported, on February 11, 2020, Amgen sued Pfizer and its affiliate Hospira, alleging that their proposed biosimilar of Amgen’s NEULASTA (pegfilgrastim) would infringe U.S. Patent No. 8,273,707 (“the ’707 patent”). The ’707 patent is directed at methods of protein purification. Last week, Pfizer filed a motion to…
We previously reported on Judge Chesler’s claim construction order in Sanofi-Aventis v. Mylan et al. concerning Mylan’s proposed insulin glargine pen device, Vystra. This week, following a 5-day bench trial held on December 2-6, 2019, the U.S. District Court of New Jersey found U.S. Patent No 9,526,844, a pen-type injector…
We have previously reported on the BPCIA Genentech v. Amgen cases relating to trastuzumab and bevacizumab. This week, Judge Connolly construed the term “following fermentation” as it relates to U.S. Patent No. 8,574,869 (“the Kao patent”) to mean “after the earlier of harvesting or purification has begun.” By way of…
The Korean Herald reported today that Celltrion has applied for the European Medicine Agency’s approval of CT-P17, a Humira (adaliumumab) biosimilar. According to the Korean Herald, Celltrion “expects to introduce CT-P17 to the European market in about a year’s time, which is how long the EMA typically takes to review.” …