Japanese pharmaceutical company Takeda Pharmaceutical Company Limited announced via a press release today that it is acquiring Cambridge-based oncology company ARIAD Pharmaceuticals, Inc. in an all-cash deal worth over $5 billion. Takeda expects the deal to close by the end of February 2017, subject to required regulatory approvals and other customary…
In August 2016, we reported that CVS dropped Neupogen® (filgrastim) and Lantus® (insulin glargine) from its standard formulary and replaced them with biosimilar versions. Hikes in insulin drug prices have prompted pharmacies and insurers to change their formularies in favor of biosimilar alternatives, as reported this week by USA Today. In…
Goodwin and the Big Molecule Watch team are looking forward to participating in the 35th Annual J.P. Morgan Healthcare Conference, which brings together leaders from across the industry. If you will be in San Francisco for the conference, we hope you will join us next Wednesday, January 11, 2017, for…
For the past few years, Amgen has been asserting patents in a litigation against Sanofi and Regeneron Pharmaceuticals in the District of Delaware to prevent them from selling Praluent® (alirocumab), a biologic that competes with Amgen’s Repatha® (evolucumab). Both products are monoclonal antibodies that target PCSK9 to lower the levels…
Pfizer announced today that PF-06410293, its proposed biosimilar to Humira® (adalimumab), has demonstrated equivalent efficacy to Humira® in a clinical study. The clinical study gathered data from a 12 week trial in which patients with rheumatoid arthritis were randomized to receive either Humira® or the proposed biosimilar, both in combination with…
On January 3, 2017 in the Amgen v. Sanofi/Regeneron action, Judge Robinson denied Defendants’ motion for judgment in their favor as a matter of law (JMOL) and request for a new trial regarding written description and enablement of the asserted claims of the patents-in-suit. On March 16, 2016, after a trial,…
Yesterday, in the Janssen v. Celltrion action, Janssen filed a supplemental brief on the issue of whether Hospira may be liable for infringement on the theories of joint enterprise, agency, or contract. As we previously reported, the Court ordered the parties to brief this issue after it arose during oral arguments on the motions for…
Merck Sharp & Dohme filed two petitions for inter partes review of Genentech’s U.S. Patent 6,331,415, one of the “Cabilly Patent,” which claims processes and materials broadly applicable to recombinant antibody manufacturing. Today, the PTAB granted one of those and denied the other. IPR2017-00047 was filed along with a motion…
After another milestone year, here are our picks for the top-five biggest deals in the world of biosimilars in 2016: 1) As we reported in January 2016, Mylan N.V. and Momenta Pharmaceuticals, Inc. entered into an exclusive agreement to jointly develop, manufacture, and commercialize six of Momenta’s current biosimilar medications,…
Here are our picks for the top-five most significant foreign market developments in the world of biosimilars in 2016: 5. Various guidance documents have been published this year further defining regulatory requirements for biosimilars. The World Health Organization (WHO) proposed a naming convention for biological active substances. Specifically, the WHO…