Policy

The Center for Biosimilars® recaps the top news for the week of April 15, 2019.
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.
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.
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.
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.
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.
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.
The Center for Biosimilars® recaps the top news for the week of April 8, 2019.
Nordic countries with highly competitive public tenders are among the markets that have seen the greatest success with adopting biosimilars and reaping their cost-saving rewards. Yet Sweden, unlike its neighbors, has decentralized healthcare budgets and policies in its 21 county councils, and has seen more variable uptake of biosimilars.
Before the Senate Finance Committee, pharmacy benefit managers said legal issues, not their actions, were to blame for keeping biosimilars from reaching US patients.

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