Last week, both Wisconsin and West Virginia passed legislation intended to facilitate the dispensing and substitution of biosimilar products. Wisconsin and West Virginia join Michigan, which enacted House Bill 4472 on February 28, as the latest states to approve biosimilar access bills. On Wednesday, Wisconsin Governor Scott Walker signed Senate…
In a letter sent on Wednesday, March 28, 2018, to the CEO of the United States Pharmacopeial Convention, FDA’s Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research, and Dr. Janet Woodcock, Director of the Center for Drugs Evaluation and Research, raised FDA’s concerns that USP’s proposed…
A number of media sources have covered new developments in the biosimilars space. Here is a round-up of some highlights from this month. Reuters reports that biosimilars, including biosimilar versions of Rituxan and Herceptin, have begun to capture a large portion of the British biosimilar market, whereas approvals and adoptions…
Biocon announced yesterday that it has received marketing authorization approval from the European Commission for Semglee™ (insulin glargine). The decision came after receiving a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. According to the press release, this is the first…
Over the past several weeks, there have been numerous developments in U.S. patent litigation activity relating to biosimilars of Neupogen® (filgrastim) and Neulasta® (pegfilgrastim). Below is a summary of these developments. Amgen v. Adello: New BPCIA Complaint First, on March 8, 2018, Amgen filed a complaint against Adello Biologics in the…
Below is our first quarter update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our previous quarterly updates (Q3 2016, Q4 2016, Q1 2017, Q2 2017, Q3 2017, Q4 2017).
A recent white paper from the Association for Accessible Medicines (AAM) highlighted the continued need to lower prescription drug prices. According to the paper, up to half of all patients fail to adhere to their medication regimen, which is due in part to high drug costs. This, in turn, “is…
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…
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…