Policy

The Center for Biosimilars® spoke with Kashyap B. Patel, MD, about his work in promoting biosimilar uptake and his upcoming book on the importance of living life and not fearing death.

Biologics are not cheap, and if you can get biosimilars into the hands of patients, you’ve got something going. A strategist describes the step-by-step process that made this possible at Kaiser Permanente.

Although more advanced than in the United States, biosimilars markets in Europe may discourage competition over the long term, said officials from Medicines for Europe.

The Center for Biosimilars® (CfB) spoke with Adrian van den Hoven, director general of Medicines for Europe, and Diogo Piedade, market access manager for Medicines for Europe, about their scorecard report for biosimilar access in European markets.

President Trump signed 4 executive orders that would lower prices of prescriptions medications including insulin products and cancer medicines.

In a webinar this week, experts discussed the business dynamics that prevent providers from being able to choose the lowest-cost biosimilars.

An upcoming webinar from MJH Life Sciences™ will address the payer rebate deals that limit provider choice of biosimilars and complicate clinical pharmacy operations.

The House Appropriations Committee has called upon CMS to increase access to biosimilars.

Wayne Winegarden, PhD, director of the Center for Medical Economics and Innovation, explains that misaligned incentives are preventing the United States from realizing full benefit from biosimilars.

A new scorecard system developed by IQVIA rates the health and sustainability of biosimilars markets across Europe.

Christine Simmon, executive director of the Biosimilars Council and senior vice president of policy and strategic alliances at the Association for Accessible Medicines (AAM) discussed the new pathway for insulin biosimilars and the struggles between payers and providers over biosimilar choice.

In response to pharmaceutical supply chain disruptions caused by the coronavirus disease 2019 (COVID-19) pandemic, a panel of experts called for big changes; attention to detail is key to making sure the outcomes are successful.

Following in the footsteps of British Columbia, other Canadian provinces are working to implement their own biosimilars initiatives that would switch patients from some of the most costly reference biologics to biosimilar counterparts.

Ted Mathias and Stacie Ropka, PhD, both patent attorneys and partners at Axinn, Veltrop and Harkrider LLP, discuss patent exclusivity for biological drugs and other important issues that need to be addressed whether or not the ACA and the Biologics Price Competition and Innovation Act (BPCIA) are ruled invalid.

Ha Kung Wong, JD, a patent law attorney with Venable of New York, New York, discusses recent regulatory actions to promote biosimilars.

Amid the coronavirus disease 2019 (COVID-19) pandemic, the FDA issued guidance stressing the importance that manufacturers notify it of discontinuations and manufacturing interruptions so that the agency can implement contingency measures.

Two doctors call for interchangeability requirements for biologics to be waived for insulin products under the new regulatory pathway under the Biologics Price Competition and Innovation Act (BPCIA) of 2009.

Life under the new biologics pathway will be easier for some drugs than others, notes Stacie L. Ropka, PhD, JD, a patent attorney with Axinn, Veltrop & Harkrider LLP, in Hartford, Connecticut.

“We're always under the tyranny of the 10-year budgetary window that the CBO [Congressional Budget Office] models under,” said Rep. Michael C. Burgess, MD, R-Texas, in a discussion of the limitations of the US system for bringing biosimilars to the market.

Legal and industry experts ponder whether expanded access to biosimilars is a way around patent thickets that slow the launch of approved biosimilars.

Two new bills aimed at increasing access to biosimilars and saving billions of dollars in out-of-pocket costs have been introduced in Congress. Both have been referred to committees for further review.

Sheila Frame, the vice president of marketing, market access, and patient services at Sandoz, discusses US biosimilar policies in development and the impact they will have on the market at the World Biosimilar Congress 2020 at the Festival of Biologics USA in San Diego, California.

The Center for Biosimilars® recaps the top stories for the week of March 9, 2020.

As regulators work to increase competition and lower costs in the insulin market, CMS has released a new Medicare model intended to lower co-pays for insulin products to a maximum of $35.

Two regulatory experts said in an editorial that suffixes for biosimilars can support adverse event reporting and build provider and patient confidence in biosimilars.

There are several pending legislative proposals in both the House of Representatives and the Senate designed to encourage more commercialization of biosimilars, but the 2020 election may determine their timing.

Although biosimilar insulins are available in Europe, there are none in the United States currently, although that is slated to change.

The Center for Biosimilars® recaps the top stories for the week of March 2, 2020.

Katie Verb, director of policy and research for the biopharmaceutical industry group PhRMA, discusses recent policy changes that have increased biosimilar uptake and additional measures that could lead to greater use of biosimilars and savings for CMS and patients.

The US biosimilars market is showing healthy vital signs, said Leah Christl, Amgen’s executive director for global regulatory and research and development policy, in a talk kicking off the World Biosimilar Congress 2020 at the Festival of Biologics USA in San Diego, California, while also reassuring the audience that her former FDA colleagues are still champions of their work.