Sources are reporting that Celltrion has received clearance from the China Food and Drug Administration (CFDA) to conduct clinical trials of Remsima (infliximab), a biosimilar of Janssen’s Remicade. This is the first time a non-Chinese company will begin clinical trials of a biosimilar mAb in China. Remsima is approved in the U.S….
On Friday, in the ongoing Amgen v. Hospira district court litigation regarding Hospira’s proposed biosimilar of Epogen®/Procrit® (epoetin alfa), Amgen filed a motion for preliminary injunction seeking to enjoin Hospira from launching its biosimilar “until Hospira has complied with the requirement of 42 U.S.C. § 262(l)(8)(A), which states that ‘[t]he subsection…
In the ongoing litigation between AbbVie and Amgen regarding Amgen’s proposed biosimilar for Humira® (adalimumab), Amgen is seeking discovery from AbbVie regarding its exchanges with other adalimumab biosimilar applicants under the BPCIA, commonly known as the “patent dance.” The parties were before the Court on May 9 for a discovery conference,…
As we previously reported, Celltrion has moved to dismiss Janssen v. Celltrion for lack of standing. On Monday, Celltrion filed its reply brief in further support of that motion. The same day, Celltrion filed a motion to compel production of documents relevant to its motion to dismiss. Specifically, Celltrion seeks documents and…
Below is our spring update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates (Summer 2016, Fall 2016, Midwinter 2017).
As we previously reported, the FDA Oncologic Drugs Advisory Committee (“ODAC”) held a public meeting today regarding Hospira’s application for its proposed biosimilar of Amgen’s Epogen®/Procrit® (epoetin alfa). Pfizer, Hospira’s parent company, has announced today that ODAC recommended approval of their proposed epoetin alfa biosimilar across all indications. According to the press release,…
On May 19, 2017, the period for submitting public comments on the FDA draft guidance on biosimilar interchangeability closed (for a discussion of the FDA draft guidance click here). The draft guidance was published on January 17, 2017 and the comment period for the notice was extended in response to several requests for…
Cinfa Biotech, a Spanish company focusing on the development of biosimilars, announced positive results from their second clinical trial evaluating a biosimilar version of Amgen’s Neulasta (pegfilgrastim). According to the company’s press release, the trial demonstrates that Cinfa Biotech’s biosimilar is comparable to Amgen’s Neulasta in terms of pharmacodynamics, immunogenicity, and…
We previously reported that Apotex filed a Citizen’s Petition requesting that FDA require biosimilar applicants to conduct comparative clinical efficacy studies in at least one intended patient population, rather than conducting such studies only in healthy subjects. Apotex noted in its petition that Coherus has filed an aBLA for a Neulasta…
As we previously reported, the FDA announced that the Oncologic Drugs Advisory Committee (ODAC) will hold a public meeting on May 25, 2017 to discuss Hospira’s application for a proposed biosimilar of Amgen’s Epogen®/Procrit® (epoetin alfa). The FDA has now posted meetings materials associated with the May 25th meeting. The…