Regulatory

In the Leadup to EU Elections, Biosimilar and Generics Group Calls for Sustainable Market Policies

May 1st 2019

By Kelly Davio

European elections will take place later this month, allowing EU citizens to select their representatives in the European Parliament. The elections, being held for the first time in 5 years, are particularly significant to the healthcare sector as European stakeholders seek to reduce disparities in access to care, guard against drug shortages, and ensure a sustainable market for pharmaceuticals.

Balancing Drug Costs, Access, and Innovation: 2 Obama Administration Officials Weigh In

April 29th 2019

By Allison Inserro

“The path forward requires a sustainable, fair payment system in which drug prices reflect the value provided and reward innovations that improve outcomes,” wrote Robert M. Califf, MD, and Andy Slavitt.

CHMP Issues Positive Recommendation for Juta Pharma's Pegfilgrastim Biosimilar

April 29th 2019

By The Center for Biosimilars Staff

Last Friday, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Juta Pharma’s pegfilgrastim biosimilar, Grasustek.

The Top 5 Biosimilars Articles for the Week of April 22

April 26th 2019

The Center for Biosimilars® recaps the top news for the week of April 22, 2019.

FDA Approves Samsung Bioepis' Etanercept Biosimilar, Eticovo

April 26th 2019

By Kelly Davio

The FDA has approved Samsung Bioepis’ etanercept biosimilar, SB4, as Eticovo (etanercept-ykro). A representative from Samsung Bioepis has confirmed approval of the product to The Center for Biosimilars® in an email. The biosimilar is already approved in a variety of other markets under the name Benepali.

Could Novartis' Brolucizumab Beat Biosimilar Anti-VEGFs in Ophthalmology?

April 20th 2019

By Kelly Davio

This week, the FDA granted priority review to Novartis’ innovator biologic, RTH258, brolucizumab. The vascular endothelial growth factor (VEGF) inhibitor is intended to treat wet age-related macular degeneration.

The Top 5 Biosimilars Articles for the Week of April 15

April 19th 2019

The Center for Biosimilars® recaps the top news for the week of April 15, 2019.

European Parliament Votes in Favor of SPC Waivers for Generics and Biosimilars

April 18th 2019

By Kelly Davio

Yesterday, the European Parliament approved a proposal to allow waivers of supplementary protection certificates (SPCs) for EU generics and biosimilars by a vote of 572 to 36.

IGBA Outlines Steps Needed for a Successful Biosimilar Regulatory System

April 17th 2019

By Kelly Davio

According to The International Generic and Biosimilar Medicines Association (IGBA)’s paper, despite global progress in strengthening the regulatory system for medicines, progress related to biologics and biosimilars has been less robust.

Left Hand/Right Hand: Does the Administration Know that FDA Is Undermining Its Efforts to Lower Patient Drug Costs via Biosimilar Competition?

April 17th 2019

The FDA is committing a serious policy misstep that puts this progress at risk by adding a random, meaningless 4-letter suffix to the names of biosimilar products that are approved to treat the same diseases as their reference biologics.