Regulatory

The Top 5 Biosimilars Articles for the Week of September 16

September 20th 2019

The Center for Biosimilars® recaps the top stories for the week of September 16, 2019.

In Antitrust Case Over Remicade, J&J Wins the Right to Arbitration

September 16th 2019

By Kelly Davio

The United States Court of Appeals for the Third Circuit has sided with Johnson & Johnson (J&J) and its Janssen division, requiring a dispute between the Remicade maker and Rochester Drug Cooperative to be sent to arbitration.

Ustekinumab Gets Expanded European Label With New Ulcerative Colitis Indication

September 8th 2019

By The Center for Biosimilars Staff

Janssen, a unit of Johnson & Johnson, announced this week that the European Commission has approved its ustekinumab (Stelara) for the treatment of moderate to severe ulcerative colitis. Also approved in the European Union to treat plaque psoriasis, psoriatic arthritis, and Crohn disease, the biologic is the first available therapy that targets the interleukin-12 and -23 pathway.

In Agreement With Genentech, JHL Must Destroy Its Biosimilar Cell Lines and Banks

September 6th 2019

By Kelly Davio

Genentech has reached a memorandum of understanding with JHL Biotech in its civil lawsuit related to the theft of Genentech’s trade secrets.

The Top 5 Biosimilars Articles for the Week of September 2

September 6th 2019

The Center for Biosimilars® recaps the top stories for the week of September 2, 2019.

Health Canada Updates Its Biosimilar Fact Sheet

September 3rd 2019

By Allison Inserro

Health Canada recently updated its fact sheet on biosimilars, including new or clarified information about key topics including interchangeability and switching.

Mylan and Biocon Get a Second CRL for Insulin Glargine Follow-on

September 3rd 2019

By Kelly Davio

Over the weekend, drug maker Biocon disclosed that it and partner Mylan have been issued a second Complete Response Letter (CRL) for their follow-on insulin glargine product referencing Lantus.

Eculizumab Approved in Europe for NMOSD, Another Candidate Moves Forward in the United States

August 28th 2019

By Allison Inserro

This week saw a pair of developments for patients with neuromyelitis optica spectrum disorder (NMOSD), a rare, severe, relapsing, neuroinflammatory autoimmune disease that can be fatal.

Global Coalition of Regulators Voices Confidence in Biosimilars

August 25th 2019

By The Center for Biosimilars Staff

The International Coalition of Medicines Regulatory Authorities, an executive-level coalition of regulators from 29 medicines regulatory authorities from territories including Australia, Brazil, Canada, China, the European Union, and the United States, among others, recently released a statement of confidence in biosimilars.

The Top 5 Biosimilars Articles for the Week of August 19

August 23rd 2019

The Center for Biosimilars® recaps the top stories for the week of August 19, 2019.