On February 21, 2019, Sandoz initiated a lawsuit against Amgen in the Northern District of California seeking a declaration that its biosimilar filgrastim and pegfilgrastim products do not infringe the Amgen’s ’997 patent. The ’997 patent relates to a method of protein purification and is in the same patent family…
Last week, Health Canada announced that biologic drugs, including biosimilars, will be identified “by their unique brand name and non-proprietary (common) name, without the addition of a product-specific suffix. Both the brand name and non-proprietary name should be used throughout the medication use process so that biologics that share the…
Alvotech announced today that its current product pipeline of “six biosimilar monoclonal antibodies aimed at treating cancer, autoimmune, inflammatory and other diseases” will receive an injection of capital from funds raised through a private bond offering. Having raised US$300 million, Alvotech plan to use the net proceeds “to fuel continued…
Yesterday, Kashiv Pharma, LLC announced its acquisition of the assets of Adello Biologics, LLC, a biotechnology company developing biosimilars. Kashiv will now be known as Kashiv BioSciences, LLC with its headquarters in Bridgewater, New Jersey. It also has research and development and manufacturing facilities in Bridgewater, New Jersey, Piscataway, New…
The United Kingdom’s National Health Service (NHS) recently announced that in its last fiscal year, it had saved $419 million in switching to biosimilar and generic versions of ten expensive drugs. These savings exceeded the $324 million in savings the NHS had forecasted. According to the announcement, most of the…
On July 23, 2018, Congressman John Sarbanes (D-Md.) introduced a bipartisan bill, the Biosimilars Competition Act of 2018, meant to curb “pay-for-delay” agreements entered into by biologic and biosimilar drug manufacturers. According to Congressman Sarbanes, the purpose of the bill is to help lower the cost of prescription drugs by affirmatively giving…
Last week Biocon announced that it has received EU GMP certification for its biosimilars facility in Bangalore, after an inspection by European agencies this past March. Biocon’s Bangalore biosimilar facilities were also inspected earlier this year by the FDA, and last month Biocon announced the FDA issued an Establishment Inspection Report stating “that the inspection stands…
Today, we’re catching up with news from around the industry. Amgen recently announced top-line results from a Phase 3 study evaluating its infliximab biosimilar candidate, ABP 710. According to the announcement, the study, a randomized, double-blind trial of 558 patients over 22 weeks, demonstrated the non-inferiority of ABP 710 to…
As we previously reported, in September 2017 FDA issued draft guidance entitled Statistical Approaches to Evaluate Analytical Similarity that “describes the type[s] of information a sponsor of a proposed biosimilar product should obtain” to support a showing of analytical similarity to a licensed reference product biologic. Today, FDA withdrew this draft guidance….
As we reported last month, many state legislatures have passed or are considering biosimilar substitution bills. Alaska, Connecticut, New Hampshire, and Vermont are the latest states to join this list. Last week, the Alaska legislature passed SB 32, entitled “Prescriptions for Biological Products,” which allows substitution of “an interchangeable biological…