Regulatory

FDA Approves Pfizer's Trastuzumab Biosimilar, Trazimera

March 12th 2019

By The Center for Biosimilars Staff

The FDA has approved Pfizer’s trastuzumab-qyyp (Trazimera), a biosimilar referencing Herceptin.

Developers Call FDA Guidance on Suffixes a "Direct Blow" to Biosimilars

March 8th 2019

By Kelly Davio

After the FDA published updated draft guidance on the naming of biologics, biosimilars, and interchangeable biosimilars, biosimilar developers were quick to voice their concerns. According to industry, the FDA’s decision to require 4-letter, nonmeaningful suffixes for biosimilars, interchangeable biosimilars, and new biologics—but not already approved biologics—could seriously hinder biosimilar uptake.

The Top 5 Biosimilars Articles for the Week of March 4

March 8th 2019

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

FDA Releases Guidance on Biologic, Biosimilar, and Interchangeable Biosimilar Naming Conventions

March 7th 2019

By Kelly Davio

The FDA has issued an updated draft guidance on the naming of biologics, biosimilars, and interchangeable biosimilars.

New Drug Pricing Legislation Introduced in Maryland

March 6th 2019

By Allison Inserro

A few weeks after the United States Supreme Court rebuffed Maryland in its attempt to regulate drug prices, legislative committees are meeting Wednesday on a drug price transparency bill, as well as a bill to create a commission to review prices and set ceilings on insurers, pharmacies and hospitals.

How Will Biosimilars Fare in the FDA Post Gottlieb and Christl?

March 6th 2019

By Kelly Davio

News that FDA Commissioner Scott Gottlieb, MD, will step down from his position in 1 month’s time took stakeholders by surprise on Tuesday and raises questions about how the agency will approach biosimilars when it comes under new leadership. While Gottlieb’s departure has garnered the most attention, it is not the only recent FDA shake-up that could have an impact on the agency’s approach to biosimilars; Leah Christl, PhD, previously the director of the Therapeutic Biologics and Biosimilars Staff in the Office of New Drugs, left the FDA in February 2019.

Report Shows Ties Between Patient Groups, Pharma in Ads Opposing Administration's Step Therapy Plan

March 5th 2019

By Allison Inserro

A Kaiser Health News (KHN) analysis found that about one-half of the patient advocacy groups appearing in national ads opposing a Trump administration proposal to change how Medicare Part D covers drugs in protected classes have received pharmaceutical industry funding.

Ahead of the Arrival of US Biosimilar Trastuzumab, FDA Approves Subcutaneous Herceptin

March 5th 2019

By Kelly Davio

The FDA has approved a subcutaneously administered version of the brand-name trastuzumab, Herceptin. The new formulation, trastuzumab and hyaluronidase-oysk, is a combination of the anticancer agent trastuzumab and an endoglycosidase that allows for the administration of higher volumes and enhanced absorption, and it has been approved under the name Herceptin Hylecta.

Eli Lilly Launching Lower-Priced Authorized Generic of Its Insulin Lispro

March 4th 2019

By Allison Inserro

Eli Lilly and Company said Monday it is introducing a lower-priced authorized generic of its insulin lispro injection (Humalog) in the United States. The generic will have a list price 50% lower than the current Humalog list price.

With No-Deal Brexit Looming, UK and EU Regulators Urge Timely Action from Drug Makers

February 28th 2019

By Kelly Davio

As the United Kingdom continues to move toward its exit from the European Union without an agreed-upon deal, the UK National Institute for Biological Standards and Control has issued new guidance for manufacturers of biologics in preparation for a no-deal Brexit, and the European Medicines Agency issued a new communication to drug makers seeking Brexit-related Type 1 variations to their marketing authorizations.