On October 19, 2017, Abzena plc and UGA Biopharma Gmbh announced that their partnership completed development of an NS0 (murine myeloma) manufacturing cell line. This cell line expresses a biosimilar of a therapeutic antibody for multiple sclerosis. While the press release does not disclose the originator therapeutic, it notes the…
We reported earlier this month that, in early October, Genentech filed a complaint under seal against Amgen in the District of Delaware based on Amgen’s FDA-approved aBLA for MVASI® (bevacizumab-awwb), a biosimilar of Avastin®. Yesterday, a redacted version of that Complaint became available on the public docket. There is also a…
Intas, an Indian pharmaceutical company based in Ahmedabad, has launched BEVATAS (bevacizumab), a biosimilar to Roche’s AVASTIN, in India. Bevacizumab is used to treat colorectal cancer, ovarian cancer, cervical cancer, lung cancer and recurrent glioblastoma. Bevacizumab has been available in India since 2004. Intas’s BEVATAS product is priced at 40%…
Today, Judge Bryson, a Federal Circuit judge sitting by designation in the U.S. District Court for the Eastern District of Texas, Marshall Division, issued an Opinion and Order granting Allergan’s motion to join the St. Regis Mohawk Tribe (“the Tribe”) as a party to this litigation regarding the drug Restasis®. …
The Federal Trade Commission (FTC) is hosting a workshop on November 8, 2017 at the Constitution Center in Washington, DC entitled: “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.” The workshop will address, among other things, competition for biologics under the BPCIA framework. The workshop will be…
As we previously reported, on August 2, 2017, AbbVie filed a complaint against Boehringer Ingelheim (BI) in the U.S. District Court for the District of Delaware regarding BI’s aBLA for a biosimilar version of AbbVie’s Humira® (adalimumab) product. We also reported last month that BI answered AbbVie’s complaint, and included counterclaims against AbbVie for invalidity…
Last week, Cinfa Biotech S.L. announced that the European Medicines Agency (EMA) has accepted its application to market a molecule referred to as B12019, a biosimilar of Amgen’s Neulasta® (pegfilgrastim), for the treatment of chemotherapy-induced neutropenia. To support its application, Cinfa conducted two studies confirming the analytical and biofunctional similarity…
As we posted previously, Biocon and Mylan are jointly developing a pegfilgrastim biosimilar, and have sought marketing authorization in the US. On October 10, Biocon reported that the FDA issued a Complete Response Letter (CRL). According to Biocon, the CRL relates to “pending update of the BLA with certain CMC data from…
We previously reported that on October 6, 2017, Amgen filed a declaratory judgment action against Genentech regarding Amgen’s recently approved biosimilar of Avastin® (bevacizumab-awwb). On the same day, Genentech filed a complaint in the District of Delaware, Civil Action No. 1:17cv1407. While the complaint was filed under seal, according to a motion to transfer…
On Friday, October 6, Amgen filed a complaint in the Central District of California seeking a declaratory judgment against Genentech that Mvasi® (bevacizumab-awwb), Amgen’s recently approved biosimilar of Avastin®, does not infringe 27 patents, that those patents are invalid, and that one of the patents is unenforceable for inequitable conduct….