Diabetes

Russia May Open the Spigot on Biosimilars

April 13th 2020

By Skylar Jeremias

Russia has rebuilt its pharmaceutical industry following the demise of the former Soviet-led government, and emerging companies such as Geropharm are looking for markets abroad.

"Not So Different": How the BPCIA Transition Will Affect Biosimilar Uptake

April 10th 2020

This week on the podcast, we’re speaking with the executive director of the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC), Cate Lockhart, PharmD, PhD, about the acceptance process for biosimilars in the United States, what BBCIC is doing to help the market develop, and how the new approval pathway for biologics will affect the pace at which biosimilars come to market.

Lannett Will Discuss Insulin Glargine Application With FDA

April 8th 2020

By Tony Hagen

Longtime generics manufacturer Lannett is moving an insulin glargine biosimilar development plan forward and announced an upcoming meeting with the FDA. The agent would compete with the reference product Lantus.

FDA Clears Biocon's Insulin Factory in Malaysia

April 1st 2020

By Tony Hagen

After a number of issues raised by the FDA about plant quality, Biocon has gotten clearance for its Malaysia insulin plant and now awaits FDA marketing authorization for Semglee, its insulin glargine agent.

Physicians Urge FDA to Waive Interchangeability Standard for Insulin Biosimilars

March 30th 2020

By Skylar Jeremias

Two doctors call for interchangeability requirements for biologics to be waived for insulin products under the new regulatory pathway under the Biologics Price Competition and Innovation Act (BPCIA) of 2009.

CMS Launches Model That Caps Insulin Co-pays at $35

March 12th 2020

By Skylar Jeremias

As regulators work to increase competition and lower costs in the insulin market, CMS has released a new Medicare model intended to lower co-pays for insulin products to a maximum of $35.

Study Outlines Development of Insulin Biosimilars and Cost Reductions

March 7th 2020

By Skylar Jeremias

Although biosimilar insulins are available in Europe, there are none in the United States currently, although that is slated to change.

The Top 5 Biosimilars Articles for the Week of March 2

March 6th 2020

The Center for Biosimilars® recaps the top stories for the week of March 2, 2020.

The Top 5 Biosimilars Articles for the Week of February 24

February 29th 2020

The Center for Biosimilars® recaps the top stories for the week of February 24, 2020.

Biocon Says FDA Issues Form 483 to Insulin Plant in Malaysia

February 28th 2020

By The Center for Biosimilars Staff

This is the third Form 483 Biocon has received for the insulin plant in 3 years.