On July 18, 2018, the FDA released a Biosimilar Action Plan that is aimed at promoting competition and affordability across the market for biologics and biosimilar products. The Plan uses four key strategies to accomplish...more
During a speech on May 22, 2018 at the Alliance for Regenerative Medicine's Annual Board Meeting, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced that the FDA plans to alert companies that “certain...more
On October 9, 2017, California Governor Jerry Brown signed the new drug price transparency bill SB 17. The new law requires pharmaceutical companies to give 60 days’ notice to state and health insurers if they plan to raise...more
On August 2, 2017, the U.S. Food and Drug Administration approved the use of Imbruvica® (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) to Pharmacyclics LLC. Imbruvica® is the...more
Janssen Biotech Inc. and Celltrion Healthcare have taken the next step over Janssen’s blockbuster arthritis biologic medicine Remicade (infliximab) and Celltrion’s biosimilar, as required by the Biologics Price Competition...more
7/1/2017
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