Earlier today, FDA Commissioner Scott Gottlieb, MD, gave a speech focusing on biosimilars at America’s Health Insurance Plans’ National Health Policy Conference in Washington, D.C. In his speech, Commissioner Gottlieb highlighted a 2017 study by QuintilesIMS that observed significant cost savings and dramatically expanding patient access in the EU from biosimilars…
Last month, the PTAB issued decisions on two petitions, IPR2017-02063 and IPR2018-00016, filed by Pfizer against one of Genentech’s Herceptin® (trastuzumab) patents, U.S. Patent No. 7,846,441 (“the ‘441 patent”). The ‘441 patent has claims directed to methods of treating a malignant progressing tumor or cancer characterized by overexpression of ERBB2 receptor. IPR2017-02063…
Sources are reporting that Korean pharmaceutical company Daewoong Pharmaceutical announced today that it has launched Samfenet, a biosimilar to Roche’s HERCEPTIN® (trastuzumab), in Korea. Samfenet is priced at a 29.5-percent discount to Herceptin, which amassed around $6.5 billion in global revenue last year. Mylan announced last week that it has…
South Dakota passed a law that allows pharmacists to automatically substitute a biosimilar for a prescribed biological product. According to the new law, which was signed by South Dakota’s governor on February 12, 2018, the biosimilar must be “interchangeable” with the prescribed biological product under 42 U.S.C. § 262(k)(4) to qualify…
As we’ve reported on previously, Allergan, Inc. assigned its rights to patents covering its Restasis® dry eye treatment to the St. Regis Mohawk Tribe (“Tribe”) and simultaneously licensed back those patents in exchange for the Tribe’s agreement to invoke tribal sovereign immunity in inter partes review (IPR) proceedings before the…
On February 21, 2018, Biocon reported that the FDA issued a Form 483 with six observations after the FDA completed a pre-approval inspection of the facility where Biocon plans to manufacture, in collaboration with Mylan, its follow-on insulin version of Lantus. Biocon indicated that it intends to respond to the FDA in…
JHL Biotech Inc. announced last week that it received approval from the Bulgarian Drug Agency for a Phase I clinical trial of its proposed bevacizumab (Avastin) biosimilar, JHL1149. The trial, set to begin in March 2018, will consist of a three-arm pharmacokinetic study in healthy volunteers. The data acquired from…
Genentech v. Pfizer (trastuzumab): On February 12, 2018, the parties filed a joint status report. Among other things, the parties offered their competing proposals for discovery deadlines. The parties stated that they have been “engaged in the exchanges of information provided under the” BPCIA and that Pfizer provided its notice of…
The Association of Accessible Medicines (“AAM”) released a white paper on avoiding shortages and ensuring drug competition for patients in America. AAM is advocating for the uninterrupted availability of lower-cost generic and biosimilar medicines. In the paper, AAM asserts that by placing biosimilar medicines on a level competitive playing field with…
According to a Celltrion press release, this week investigators presented twelve-month data from a UK-wide, three-year prospective observational study showing comparable efficacy between CT-P13 (Celltrion’s biosimilar infliximab), reference infliximab (Johnson and Johnson’s Remicade), and adalimumab (AbbVie’s Humira). The press release reports that the Personalised Anti-TNF therapy in Crohn’s disease Study…