Policy

Under the Biden administration, the Department of Justice (DOJ) has reversed course and now backs the constitutionality of the Affordable Care Act (ACA).

Biosimilar competition took a big chunk of revenue from Roche's aging blockbusters in 2020, and the company is banking on its newer medicines to drive fresh revenue growth.

Physician specialty and practice setting each play a significant role in whether biosimilars are administered vs originators, according to a large, cross-sectional study.

The pharmacy benefit manager reported 90% biosimilar uptake among its health plans that adopted clinical management policies that included step therapy or parity usage.

It took Henlius years to get a rituximab biosimilar approved in China. Now, that process could be cut in half, owing to significant regulatory reforms.

Consistency of reporting quality attributes for biosimilars may differ, complicating the job of getting a full picture of biosimilarity.

Coherus BioSciences CEO Dennis M. Lanfear discusses the company's biosimilar marketing prospects in 2021.

The Center for Biosimilars® reports on developments at the International Generic and Biosimilar Medicines Association (IGBA), Celltrion, Innovent Biologics, and Kamada.

CMS looks to speed up health information transfer by putting faxes in the past. It also aims to set deadlines for payers to respond to prior authorization requests.

Lawrence A. Hill, PharmD, MBA, RPH, BCPS, provided an insider's view of the rapidly changing biologics and biosimilars market and regulatory structure in China.

Authors of a review found that biosimilar uptake and market share are not in themselves sufficient to establish whether these agents will lead to savings.

Providers should feel confident using Mvasi, a bevacizumab biosimilar, for all indications of the reference product (Avastin), reviewers stated.

Many firsts may be in store for the biosimilar industry in 2021, although it will be dogged by ongoing difficulties, Center for Biosimilars® Advisory Board members said.

In part 2 of this year-end feature, we look at the most-read biosimilar stories of the second half of 2020.

The Canada Health approval for Hyrimoz will be followed by a launch in February 2021, Sandoz Canada said.

An international group of physicians, surgeons, lawyers, scientists, and pharmacists weighs in on biosimilar policy differences and deficiencies in the United States, Europe, and Japan.

In little over 1 year of use in patients with breast cancer, trastuzumab biosimilars have seen rapid growth in uptake.

We sat down with Jennifer Snow, MPH, vice president of Reimbursement and Policy Insights at Xcenda, to talk about health care reform efforts and how these would be affected by the change in administration.

To spur more biosimilar development and reduce anticompetitive practices, the company argued the FDA could improve its interpretation of the term “strength” in the Biologics Price Competition and Innovation Act (BPCIA).

In November, the Supreme Court heard arguments on the Affordable Care Act, Europe fired up its efforts to create a more biosimilar-friendly environment, and Genentech fought to protect its bevacizumab franchise.

The European Commission (EC) said it will take the lessons learned from the coronavirus disease 2019 (COVID-19) pandemic and build a better marketplace for generics and biosimilars.

Bincy P. Abraham, MD, explains that even when payers allow coverage for biosimilars, providers may still be hesitant to use them.

Prior to the turmoil of the pandemic, the FDA and CMS were at work on shoring up the biosimilars market, and this work continues on various fronts, a regulatory/policy expert explains.

Despite a rocky power transition at the federal level, the compass heading for biosimilars is unchanged, said policy expert Molly Burich.

In Europe, the pandemic has revealed problems within health care systems and the need to increase access to biosimilars and reform health care policies.

Medicines for Europe, a generic and biosimilar trade association, contends in a white paper that legal and regulatory loopholes increasingly keep competing drugs off the market.

This study of specialty drug spending looks beyond rebates to evaluate growth in spending from 2010 to 2017.

The American College of Rheumatology (ACR) has joined with other provider groups in opposing a UnitedHealthcare (UHC) plan that could increase patient out-of-pocket costs.

Arnold Ventures suggests ways the FDA and other governmental entities can get more biosimilars into circulation, faster.

A retrospective analysis of data from the US Veterans Affairs Healthcare System database provides positive switching data for infliximab products.