The Economic Times of India has reported on a study of the Indian biosimilars market conducted by the Jawaharlal Nehru Institute of Advanced Studies (JNIAS). The study reports that the Indian biosimilars industry was close to $300 million in 2015, with domestic sales accounting for $250 million growing at a…
As we covered in a previous post, Apotex has filed a cert. petition asking the Supreme Court to review the Federal Circuit’s ruling on the BPCIA’s notice provision in Amgen v. Apotex. Last week, the Biosimilars Council filed an amicus brief in support of Apotex’s petition. The brief is available here….
As we previously reported, Celltrion has moved to dismiss Janssen’s claim of infringement of the ’083 patent, the sole remaining patent in the case since the district court entered partial final judgment with respect to the ’471 patent. On October 7, 2016, Judge Wolf issued an order instructing the parties,…
Pfizer announced today that it will begin shipping INFLECTRA® (infliximab-dyyb) for injection, a biosimilar of REMICADE® (infliximab), to wholesalers in the United States (U.S.) in late November 2016. INFLECTRA® received FDA approval this past April for the treatment of inflammatory conditions including Crohn’s disease, ulcerative colitis, and rheumatoid arthritis. According…
As we previously reported, Amgen has sought to amend its complaint regarding Hospira’s planned epoetin alfa biosimilar to add three new defendants and two theories of infringement. On October 3, 2016, Judge Andrews granted-in-part and denied-in-part Amgen’s motion. First, the court denied Amgen’s request to add three defendants because “[i]t would be unreasonable to…
On October 6-7, 2016, the Medicare Payment Advisory Commission (MedPAC), a federal agency that advises Congress on Medicare pay policies, held a public meeting, with one session titled “Biosimilars in Medicare Part D.” This session concerned, among other things, market acceptance of biosimilars, including issues relating to interchangeability and costs. …
On October 11, 2016, Merck Sharp & Dohme (MSD) filed for IPR on U.S. Patent No. 6,331,415, one of the Cabilly patents owned by Genentech. IPR2017-00047. MSD also filed a motion for joinder with Mylan’s petition for IPR on this patent (IPR2016-00710), representing that its petition is based on grounds…
Last Friday, AbbVie filed its Answer and Defenses to Amgen’s counterclaims of invalidity and noninfringement for each of the patents-in-suit. Of note, AbbVie stated that it lacked “sufficient knowledge and information to form a belief” regarding Amgen’s willingness to comply with the 180 notice of intent to market, a requirement that…
Last month, researchers published results from a randomized phase I clinical trial of CT-P10, a biosimilar candidate to rituximab, comparing the pharmacokinetics parameters and safety profiles in patients with rheumatoid arthritis in the Annals of the Rheumatic Diseases. The researchers reported that in the phase I trial CT-P10 and rituximab “demonstrated equivalent pharmacokinetic and comparable…
In August, we reported that Coherus Biosciences, Inc. submitted an aBLA for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate. Last week, Coherus announced that FDA has accepted its aBLA. Under the BPCIA, Coherus has 20 days from FDA acceptance to trigger the patent dance by providing the reference product sponsor (Amgen) with a…