Regulatory

The Top 5 Biosimilars Articles for the Week of January 7

January 11th 2019

The Center for Biosimilars® recaps the top news for the week of January 7, 2019.

FDA's Scott Gottlieb, MD, Highlights Biosimilars Initiatives in J.P. Morgan Keynote Address

January 9th 2019

By Samantha DiGrande

During the 37th annual J.P. Morgan Healthcare Conference held January 7-10 in San Francisco, California, FDA Commissioner Scott Gottlieb, MD, delivered a keynote address encompassing his goals for the direction of the FDA in the coming year.

New No-Deal Brexit Guidance Holds Changes for Biosimilars

January 6th 2019

By Kelly Davio

This week, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued updated guidance for industry on preparing for the growing likelihood that the United Kingdom will leave the European Union without a trade deal.

The Top 5 Biosimilars Articles for the Week of December 31

January 4th 2019

The Center for Biosimilars® recaps the top news for the week of December 31, 2018.

Stakeholders Weigh In on the Key Biosimilar Developments of 2018

December 31st 2018

By The Center for Biosimilars Staff

2018 was an eventful year for the biosimilars marketplace. We asked experts from across stakeholder groups—and from the United States and abroad—what they felt were the most notable moments in biosimilars during 2018, and what they hope the new year holds for this developing industry.

The Top 5 Biosimilars Articles for the Year of 2018

December 28th 2018

The Center for Biosimilars® recaps the top news of 2018.

Eye on Pharma: Chong Kun Dang's Darbepoetin Alfa Biosimilar Approved

December 24th 2018

By The Center for Biosimilars Staff

This month, Korean biosimilar developer Chong Kun Dang announced that it has received approval to sell its biosimilar, CKD-11101, referencing darbepoetin alfa (Aranesp). CKD-11101 is the first biosimilar of the erythropoiesis-stimulating protein to be authorized in a highly regulated nation.

GAO Finds Trouble With Orphan Drug Designations

December 24th 2018

By Kelly Davio

Drugs that treat rare diseases are granted various incentives under the Orphan Drug Act of 1983 if they meet criteria related to the size of the rare disease population (under 200,000 people) that can be effectively treated by the drug in question. The Government Accountability Office (GAO) recently issued a report that finds serious deficiencies with the ways in which the Orphan Drug Act is administered by the FDA.

The Top 5 Biosimilar Articles for the Week of December 17

December 21st 2018

The Center for Biosimilars® recaps the top news for the week of December 17, 2018.

Senator Warren Introduces Legislation to Create Government Generic Drug Maker

December 19th 2018

By Samantha DiGrande

Senator Elizabeth Warren, D-Massachusetts, has introduced a bill in the Senate that would create an Office of Drug Manufacturing within HHS. Simultaneously, Representative Jan Schakowsky, D-Illinois, introduced an identical bill in the House of Representatives.