Policy

CMS Allows Copay Accumulator Programs to Encourage a Shift to Generic Drug

April 19th 2019

By Allison Inserro

CMS’ final 2020 Payment Notice will allow insurers to stop counting the value of manufacturer drug coupons for branded drugs towards a beneficiary’s maximum out-of-pocket costs in order to promote the use of generic drugs.

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.

Judge Grants BI's Motion to Compel AbbVie to Produce Documents in Ongoing Humira Litigation

April 18th 2019

By Kelly Davio

This month, US magistrate judge Richard A. Lloret granted Boehringer Ingelheim (BI)’s motion to compel AbbVie to produce prelitigation disclosures and settlements concerning its brand-name adalimumab, Humira.

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.

COA Releases Biosimilars Position Statement

April 16th 2019

By The Center for Biosimilars Staff

The Community Oncology Alliance (COA) recently released a position statement about biosimilars, saying it will work with stakeholders to support the acceptance of biosimilars as well as work to close knowledge gaps, given the burdensome cost of cancer care.

ICER to Review RA Therapies, Including Biosimilar Infliximab

April 16th 2019

By Kelly Davio

The new assessment, says the Institute for Clinical and Economic Review (ICER), is intended to incorporate data that have emerged since the organization reviewed rheumatoid arthritis (RA) treatments in 2017, including data related to biosimilar infliximab, Inflectra.

Bach, Coauthors Call for Regulated Pricing for Biologics as an Alternative to Biosimilars

April 15th 2019

By Allison Inserro

The 2-part proposal from Peter B. Bach, MD, and 3 coauthors published Monday argues that biosimilar competition is an economically inefficient way to achieve the goal of lower prices.

Panel Discusses Effort by Administration to Lower Drug Prices

April 13th 2019

By Allison Inserro

During the last panel at the Alliance for Patient Access 4th Annual National Policy and Advocacy Summit on Biologics and Biosimilars, panelists discussed some of the administration’s proposals, such as moving Medicare Part B drugs to Part D, a proposal to end protected drug classes in Medicare, and the International Price Index.

The Top 5 Biosimilars Articles for the Week of April 8

April 12th 2019

The Center for Biosimilars® recaps the top news for the week of April 8, 2019.