Regulatory

Mylan, Biocon Launch Insulin Glargine Biosimilar in the United Kingdom

November 23rd 2018

By Samantha DiGrande

Mylan and Biocon jointly announced earlier this month that their biosimilar insulin glargine, sold as Semglee and referencing Lantus, has launched in the United Kingdom.

The Top 5 Biosimilars Articles for the Week of November 19

November 23rd 2018

The Center for Biosimilars® recaps the top news for the week of November 19, 2018.

FDA Breaks Generics Drug Record With 128 Approvals Last Month

November 22nd 2018

By Samantha DiGrande

The FDA recently announced that it approved a record-breaking number of generic drugs in October 2018.

Novartis Submits Comments to FDA in Support of Pfizer's Citizen Petition

November 21st 2018

By Samantha DiGrande

This month, Novartis submitted a letter to the FDA in support of a citizen petition that Pfizer filed in August.

Samsung BioLogics Could Be Delisted From the Stock Market Over Fraud

November 17th 2018

By The Center for Biosimilars Staff

Samsung BioLogics, parent company of the biosimilar development business Samsung Bioepis, has been fined by the Republic of Korea’s financial regulatory body, The Securities and Futures Commission, after the commission ruled that Samsung had committed fraud.

The Top 5 Biosimilars Articles for the Week of November 12

November 16th 2018

The Center for Biosimilars® recaps the top news for the week of November 12, 2018.

Eye on Pharma: Innovent Seeks Chinese Regulatory Approval for Biosimilar Adalimumab

November 13th 2018

By Samantha DiGrande

Innovent Biologics, a China-based biopharmaceutical company, announced that its new drug application for its proposed adalimumab biosimilar IBI303, referencing Humira, was accepted by the National Medical Products Administration.

Genentech Seeks to Bar JHL From Developing 3 Biosimilars

November 10th 2018

By Samantha DiGrande

Genentech says that the biosimilar company benefited from its proprietary information, and a hearing is scheduled for December 13, 2018.

The Top 5 Biosimilars Articles for the Week of November 5

November 9th 2018

The Center for Biosimilars® recaps the top news for the week of November 5, 2018.

In a New Twist in Restasis Legal Battle, Teva Sues the FDA

November 8th 2018

By Kelly Davio

Allergan’s dry-eye drug, Restasis, has been the subject of complex legal wrangling involving the transfer of patents that could next extend to the Supreme Court of the United States. Now, in a separate twist in the story of generic competition for the cyclosporine ophthalmic emulsion, generic developer Teva has sued the FDA in the United States district court for the District of Columbia over Teva’s status as the first filer of a generic version of the drug.