Regulatory

CHMP Recommends 5 New Indications for Celltrion's Infliximab

June 29th 2020

By Tony Hagen

Based on clinical studies on dosing, efficacy, and pharmacokinetics, European authorities have recommended Celltrion's subcutaneous infliximab biosimilar (Remsima SC) for 5 new indications.

FDA Says New System for Calculating Biosimilar Fees Is Reliable

June 26th 2020

By Tony Hagen

New prediction methodology for calculating biosimilar application fees will help the FDA cover its costs and respond quickly to changes in demand, officials said at a public meeting.

Samsung Bioepis' Bevacizumab Biosimilar Gets CHMP Nod

June 26th 2020

By Skylar Jeremias

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended Samsung Bioepis’ bevacizumab biosimilar for the treatment of multiple types of cancer.

Henlius Biotech Gets NMPA Nod for Denosumab Biosimilar

June 25th 2020

By Skylar Jeremias

HLX14, a denosumab biosimilar targeted for the treatment of postmenopausal osteoporosis in patients with a high risk of fractures, was approved by China’s National Medical Products Administration (NMPA).

Part 1: Nick Mitrokostas on How COVID-19, FDA Rule Changes Are Shaping the Biosimilar Market

June 23rd 2020

Nick Mitrokostas, an intellectual property law attorney with Goodwin Proctor in Boston and editor in chief of Big Molecule Watch, discussed the impact on the US biosimilar market from the coronavirus disease 2019 (COVID-19) pandemic and the recent change to the Biologics Price Competition and Innovation Act (BPCIA).

China's NMPA Approves Innovent's Byvasda Biosimilar

June 19th 2020

By Skylar Jeremias

Innovent Biologics said China’s National Medical Products Administration (NMPA) has approved its biosimilar bevacizumab, Byvasda, for use in patients with lung and colorectal cancers.

Part 2: Christine Simmon Discusses Payer Influence on Provider Behavior

June 18th 2020

Christine Simmon, executive director of the Biosimilars Council and senior vice president of policy and strategic alliances at the Association for Accessible Medicines (AAM) discussed the new pathway for insulin biosimilars and the struggles between payers and providers over biosimilar choice.

FDA Approves Eli Lilly Insulin Lispro Formulation

June 18th 2020

By Tony Hagen

Eli Lilly gets FDA approval for a new formulation of insulin lispro and offers it at the out-of-pocket cap of $35 for a monthly supply for patients with or without insurance.

Criticism Dogs Launch of Trade Agreement

June 17th 2020

By Deana Ferreri, PhD

The United States–Mexico–Canada Agreement came to a rocky impasse over drug exclusivity protections, and July 1 is the day this agreement takes effect.

Part 1: Christine Simmon Discusses the Individual Mandate and Biosimilars

June 16th 2020

Christine Simmon, executive director of the Biosimilars Council and senior vice president of policy and strategic alliances at the Association for Accessible Medicines (AAM) discusses potential legislation that the AAM is advocating for and how the upcoming election and Supreme Court decision will affect biosimilars.