Regulatory

The Top 5 Biosimilars Articles for the Week of February 11

February 15th 2019

The Center for Biosimilars® recaps the top news for the week of February 11, 2019.

FDA Proposes Path for Voluntary Pharmaceutical Quality Standards

February 14th 2019

By Allison Inserro

The FDA this week announced draft guidance that would allow stakeholders to propose pharmaceutical quality standards for potential informal recognition to increase efficiency in drug development by achieving “voluntary consensus standards.”

FDA Releases Final Guidance on Immunogenicity Testing for Biologics and Biosimilars

February 8th 2019

By The Center for Biosimilars Staff

The FDA recently released final guidance on the use of therapeutic proteins in developing biologics and biosimilars. "Immunogenicity Testing of Therapeutic Protein Products—Developing and Validating Assays for Anti-Drug Antibody Detection" represents current FDA thinking about developing and validating assays for anti-drug antibody (ADA) detection.

The Top 5 Biosimilars Articles for the Week of February 4

February 8th 2019

The Center for Biosimilars® recaps the top news for the week of February 4, 2019.

Congress Makes a New Push for the CREATES Act

February 7th 2019

By Kelly Davio

This week, Senator Patrick Leahy, D-Vermont, reintroduced The Creating and Restoring Equal Access To Equivalent Samples (CREATES) Act.

According to Azar, "Those Against Biosimilars Are Simply on the Wrong Side of History"

February 7th 2019

By Samantha DiGrande

HHS Secretary Alex Azar offered a view of hope and optimism for the future of the American healthcare market in his remarks delivered as the closing keynote address at the Association for Accessible Medicine’s Access! 2019 meeting.

Identifying and Addressing "Biosimilar Shenanigans"

February 6th 2019

By Samantha DiGrande

“Today’s healthcare system is unsustainable. [US] national health spending is expected to grow at 5.5% each year,” said Carol Lynch, president of Sandoz US and head of North America, setting the stage for a session at the Association for Accessible Medicine’s Access! 2019 meeting. “If all approved biosimilars had been marketed in a timely manner, Americans could have saved $4.5 billion.”

Positive CHMP Opinion for 2 Brands of Fresenius Kabi's Adalimumab Biosimilar

February 4th 2019

By Kelly Davio

On Friday, Fresenius Kabi announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for its MSB11022, a biosimilar adalimumab referencing Humira. The CHMP issued its opinions for the marketing of 2 brand names of the drug: Idacio and Kromeya.

EU Seeks to Digitize Drug Information for Easier Patient Use

February 3rd 2019

By Kelly Davio

As patients are being encouraged to self-manage disease and take an active role in their healthcare, communication with patients about the products that they use is becoming a hot topic among drug makers. During the second day of the Medicines for Europe 18th Regulatory and Scientific Affairs Conference, held January 31 to February 1 in London, United Kingdom, stakeholders gathered to discuss new directions in providing digital information to patients.

Which Reimbursement Changes Can Help Encourage Biosimilar Uptake?

February 2nd 2019

By Allison Inserro

A recent white paper recaps the many barriers to biosimilar adoption in the United States and proposes a few ways that plans could change their reimbursement policies to help boost uptake.