Business

AffaMed Gets Chinese Clearance to Start Phase 3 Trial of Biosimilar Trastuzumab, SB3

December 11th 2019

By The Center for Biosimilars Staff

AffaMed Therapeutics announced this week that it has received a Clinical Trial Application (CTA) approval from Chinese regulators to conduct a phase 3 clinical trial of Samsung Bioepis’ biosimilar trastuzumab, SB3.

Biosimilar Stakeholders Praise Removal of Biologic Exclusivity Provisions From USMCA

December 11th 2019

By Kelly Davio

An agreement on the United States–Mexico–Canada Agreement (USMCA), a trade deal that updates the North American Free Trade Agreement, has been reached, and proponents of biosimilars and generics have cause to celebrate after the removal of provisions that some said would hinder competition.

Sanofi to End R&D on Diabetes, Cardiovascular Drugs

December 11th 2019

By Allison Inserro

Sanofi will retain its insulin business, but will otherwise stop research and development in diabetes and cardiovascular drugs in order to focus on cancer immunotherapies and its biologic for asthma and allergies.

Slower Price Growth, Use of Generics Balance Higher Spending on Cancer, Autoimmune Drugs

December 10th 2019

By Allison Inserro

Increased spending on new oncology and autoimmune drugs was partially offset by a decline in price growth and the continued increase in the use of generic drugs, according to a recent report from CMS about national healthcare spending in 2018.

"Not So Different": Celltrion Breaks New Ground With a Subcutaneous Biosimilar Infliximab

December 8th 2019

Just last month, the European Commission authorized a subcutaneously administered formulation of biosimilar infliximab CT-P13 for the treatment of rheumatoid arthritis. When the drug launches in the European Union, it will be first infliximab to be available in a subcutaneous formulation. This week on the podcast, we’re speaking about this new product with Mike An, head of the sales and operations division at Celltrion Healthcare.

Eye on Pharma: Alvotech and Kamada Team Up to Commercialize Biosimilars in Israel

December 7th 2019

By The Center for Biosimilars Staff

Israel-based Kamada Ltd announced this week that it has entered into an agreement with Iceland-based Alvotech to commercialize 6 biosimilar products in Israel once the products gain local regulatory approval.

FDA Approves Amgen's Infliximab Biosimilar, Avsola

December 6th 2019

By Kelly Davio

The FDA has approved Amgen’s infliximab biosimilar, Avsola (infliximab-axxq), referencing Remicade.

The Top 5 Biosimilars Articles for the Week of December 2

December 6th 2019

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

Bio-Thera Solutions Gets Clearance to Start Phase 1 Trial of Ustekinumab Biosimilar

December 5th 2019

By Allison Inserro

Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, said this week that the China National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application to initiate a phase 1 clinical study to compare the pharmacokinetics and safety of BAT2206, a proposed ustekinumab biosimilar, to the reference Stelara in healthy volunteers.

Is It Time to Look Beyond Price With Biosimilars?

December 5th 2019

By Kelly Davio

While there is no question that falling prices that come with competition are cause for optimism in the United States, which is burdened by rising drug costs, some experts from Europe caution that a focus on price alone misses key reasons to use biosimilars.