Business

The Top 5 Biosimilars Articles for the Week of November 18

November 22nd 2019

The Center for Biosimilars® recaps the top stories for the week of November 18, 2019.

GAO Report: Reference and Generic Sponsors Look Differently at FDA REMS Enforcement

November 20th 2019

By Allison Inserro

Perhaps not surprisingly, officials from generic drug companies, reference product companies, the FDA, and the Federal Trade Commission (FTC) have different opinions about the usefulness of various actions the federal government has taken to prevent abuses of risk evaluation and mitigation strategies (REMS), according to a recently released Government Accounting Office (GAO) report.

Europe Weighs the Merits of Duplicate Marketing Authorizations for Biologics

November 20th 2019

By Kelly Davio

This month, the European Commission’s Pharmaceutical Committee, part of the Health and Food Safety Directorate-General, updated EU member states as to the results of a targeted consultation it undertook in 2018 on a specific type of duplicate marketing authorization applications (MAAs) for originator biologics and their potential impact on biosimilars.

The FDA Will Review Samsung Bioepis' Proposed Bevacizumab Biosimilar, SB8

November 19th 2019

By Kelly Davio

Samsung Bioepis announced Tuesday that the FDA has accepted for review the company’s Biologics License Application (BLA) for SB8, a proposed bevacizumab biosimilar referencing Avastin. The biosimilar developer submitted the BLA in September.

Biosimilars Make Progress in the Canadian Market, but Stakeholders See More Work Ahead

November 18th 2019

By Kelly Davio

While much attention over the past few weeks has been on the US biosimilars market, with its recent approvals and product launches, Canada has also been making strides in its own biosimilars experience.

Novartis Confirms It Has Launched Biosimilar Pegfilgrastim, Ziextenzo, in the United States

November 15th 2019

By Kelly Davio

Novartis has confirmed in an email to The Center for Biosimilars® that it has launched Sandoz’s pegfilgrastim biosimilar, Ziextenzo, in the United States. According to Novartis, the wholesale acquisition cost (WAC) for Ziextenzo is $3925, or an approximate 37% discount off the WAC for the reference product, Amgen’s Neulasta.

AARP Says Brand-Name Drug Prices Outpaced Inflation Once Again in 2018

November 15th 2019

By Kelly Davio

The AARP Public Policy Institute has released a new Rx Price Watch report showing that, last year, the retail prices of 267 brand-name drugs that are commonly used by older Americans rose by an average of 5.8%—more than twice the general rate of inflation, which was 2.4%.

The Top 5 Biosimilars Articles for the Week of November 11

November 15th 2019

The Center for Biosimilars® recaps the top stories for the week of November 11, 2019.

WHO Launches Pilot Prequalification for Human Insulin

November 14th 2019

By The Center for Biosimilars Staff

The World Health Organization (WHO) this week announced its pilot procedure for the prequalification of human insulin as means to facilitate access to safe, effective, and quality-assured insulin and insulin biosimilars for type 1 and type 2 diabetes in low- and middle-income countries.

Looking to the Future, Biosimilar Pioneer Celltrion Is Banking on Biobetters

November 12th 2019

By Kelly Davio

Improvements in biosimilars—ones that may give them an advantage such as lower immunogenicity or a new route of administration—may be the key to unlocking a better patient experience, according to Celltrion. In fact, pursuing such so-called “biobetters” may prove to be more important for the drug maker than pursuing interchangeable biosimilars.