The Korea Herald reports that Archigen Biotech, a joint venture between AstraZeneca UK and Samsung BioLogics, has applied for FDA approval to begin Phase I clinical trials for its rituximab biosimilar, SAIT101. Archigen Biotech’s website states that clinical trials for SAIT101 are expected to begin globally in Q3 of 2016.
As we covered in a previous post, the Court in Amgen v. Hospira ruled on some novel issues relating to litigation under the BPCIA during a hearing on discovery issues a few months ago. Background: To recap: this past May, the district court for the District of Delaware (Judge Andrews) held a hearing to…
Today, AbbVie announced growth in Humira (adalimumab) sales to $4.15 billion worldwide in the second quarter, a 17.4% increase over the same quarter in 2015. On June 30th, AbbVie received FDA approval for a 10th indication for Humira: non-infectious intermediate, posterior and panuveitis in adults, which can severely impact vision. …
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 Brenzys, will be available as a pre-filled auto-injector and sold in Australia by Merck Sharpe & Dohme, Merck & Co.’s international subsidiary. Samsung…
The FDA has announced the rates for biosimilar user fees for the 2017 Fiscal Year: FY17 BsUFA Fees Biological Product Development Initial $203,810 Annual $203,810 Application w/Clinical Data $2,038,100 w/o Clinical Data $1,019,050 Supplement w/Clinical Data $1,019,050 Product $97,750 Establishment $512,200 Reactivation $407,620 The biosimilar user fees for a given fiscal year…
On July 22, 2016, the District Court for the District of New Jersey granted Sandoz’s motion to dismiss Amgen’s declaratory judgment action related to Sandoz’s biosimilar of Amgen’s Neulasta (pegfilgrastim). As background, Sandoz provided Amgen with required disclosures related to its pegfilgrastim biosimilar under § 262(l)(2) and (l)(3)(B) then sent Amgen a letter waiving receipt…
Epirus Biopharmaceuticals, a biosimilar startup, has filed for Chapter 7 bankruptcy. The Boston-based startup had lost approximately 82% of its value by June of 2016, after an announcement that it would cease working on a biosimilar of Remicade (infliximab) to focus on Soliris (eculizumab) and Actemra (tocilizumab), a cut in…
Goodwin released today its Guide to the Biosimilars Patent Dance, which lays out in a user-friendly format the complex statutory scheme of the so-called “patent dance” codified in subsection 262(l) of the Biologics Competition and Innovation Act (BPCIA). The BPCIA’s patent dance dictates a schedule of timed steps according to…
Cipla has announced that it is investing 1.3 billion South African Rand (approximately 91 million USD) to open a biotech plant in South Africa. According to Cipla’s press release, this will be South Africa’s first state-of-the-art biotech manufacturing facility for the production of biosimilars. The facility will have the necessary…
On July 20, Pennsylvania Governor Tom Wolf signed into law Senate Bill 514, which allows pharmacists to substitute for a brand name biological product a less expensive biosimilar product that has been deemed interchangeable by the FDA. Pennsylvania is the twenty third state to enact such a law. In particular,…