Policy

On July 20, the United States Court of Appeals for the Federal Circuit ruled in the case of the St Regis Mohawk Tribe v Mylan Pharmaceuticals that sovereign immunity does not extend to inter partes review (IPR) proceedings.

After the release of the FDA’s Biosimilar Action Plan this week, many industry stakeholders have spoken out on the actions being taken by the FDA to further competition and increase biosimilar uptake.

Catch up on the week’s top policy, clinical, business, regulatory, legal, and international news from the world of biosimilars.

This week, the Trump administration made a pair of significant policy advancements related to its ongoing efforts to reduce the price of drugs for American patients.

In its comments, the American College of Rheumatology (ACR) stressed that safe and effective treatments should be accessible to all patients at the lowest cost possible, and this mindset should be the fundamental basis for any drug-pricing policy.

The industry group representing generic and biosimilar manufacturers has issued a new report that claims that Ireland’s policies are keeping the nation from benefitting from €25 million (approximately $29 million) in annual savings to its national health system.

During a speech given today in Washington, DC, FDA Commissioner Scott Gottlieb, MD, announced the release of the long-awaited Biosimilar Action Plan.

“This is a crucial moment for the growth of biosimilars in the United States, and we are encouraged that HHS is committed to pursuing policies that reward innovation and support provider and patient access and choice,” said Juliana M. Reed, president of the Biosimilars Forum.

An analysis by consumer website GoodRx concluded that the price people pay for generic drugs at the pharmacy varies greatly based on where they live.

The FDA recently released a draft guidance document entitled “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.” The guidance is meant to address various industry inquiries around the implementation of the Biosimilar User Fee Amendments II (BsUFA II).

Catch up on the week’s top rheumatology, gastroenterology, clinical practice, regulatory, policy, and business news from the world of biosimilars.

The new rule imposes a 10% fee-for-service cut on any provider who doesn’t opt into a managed-care network, and rural hospitals are especially concerned about the financial losses the change may cause.

Last week, the European Specialist Nurses Organisations (ESNO) released a document aimed at assisting nurses in the management of switching a patient from a reference biologic to a biosimilar.

While managing costs is extremely important to physicians and their patients, achieving and maintaining disease control without increasing the risk of complications or toxicities must remain the primary goal in the treatment of chronic inflammatory diseases.

Here are the top 5 biosimilars articles for the week of June 25.

Research presented at the European League Against Rheumatism’s Annual European Congress of Rheumatology concluded that patients’ attitudes and level of satisfaction with switching to a biosimilar for etanercept or infliximab was associated with their level of health literacy, defined as being given sufficient and necessary information concerning their health.

Although no biosimilar has earned an interchangeable designation by the FDA to date, the distinction could garner more biosimilar uptake. In a presentation during the American Conference Institute’s Summit on Biosimilars, held June 25-27 in New York, New York, various stakeholders discussed how interchangeability is the future of the space.

Isaac Ashkenazi, partner at Paul Hastings LLP; Gregory Morris, PhD, partner and leader of life sciences litigation at Honigman Miller Schwartz and Cohn LLP; and John Molenda, PhD, partner and co-chair of Healthcare & Life Sciences practice at Steptoe & Johnson LLP, discussed current “hot button” litigation issues in the biosimilar sphere during the American Conference Institute’s Summit on Biosimilars, held June 25-27.

At the American Conference Institute (ACI)’s Summit on Biosimilars Conference, held June 25-27 in New York, New York, panelists Crystal Kuntz, vice president of healthcare policy and research at Biotechnology Innovation Organization, and David Korn, vice president of intellectual property and law at Pharmaceutical Research and Manufacturers of America, provided an overview of recent policy and legislative updates in regard to biosimilars.

Catch up on the week’s top rheumatology, gastroenterology, neurology, clinical practice, advocacy, regulatory, policy, and business news from the world of biosimilars.

Reuters is reporting that pharmaceutical companies may be shifting the amount of taxes they owe in the United States by holding their valuable drug patents overseas.

Senator Orrin Hatch, R-Utah, has filed an amendment to the Creating and Restoring Equal Access to Equivalent Samples Act, which was advanced to the Senate by the Judiciary Committee on June 14, 2018.

In a webcast hosted by the Alliance for Health Policy that took place earlier this week, Robert Langreth, senior health reporter for Bloomberg News, Dora Hughes, MD, MPH, senior policy advisor at Sidley Austin, LLP, and Sameer Awsare, MD, associate executive director of the Permanente Medical Group at Kaiser Permanente, came together to discuss the best ways to bring down the steadily increasing drug prices in the United States. The panel was moderated by Mary Ella Payne, RN, MSPH, president of the Alliance for Health Policy.

The Center for Biosimilars® recaps the top 5 articles for the week of June 11, 2018.

The Senate Judiciary Committee today voted 16 to 5 to report the Creating and Restoring Equal Access to Equivalent Samples Act (CREATES Act) to the Senate floor.

HHS Secretary Alex Azar today testified before the Senate’s Committee on Health, Education, Labor, and Pensions on the Trump administration’s blueprint to lower drug prices.

Walgreen and Kroger have filed an antitrust lawsuit against Johnson & Johnson (J&J) and Janssen over Remicade.

This week, a Delaware District court granted Boehringer Ingelheim’s (BI) motion to compel discovery in AbbVie v Boehringer Ingelheim, an ongoing litigation over adalimumab (Humira).

Sheila Frame, vice president and head of biopharmaceuticals, North America, at Sandoz, discusses policy challenges related to biosimilars.

The Center for Biosimilars® recaps the top 5 articles for the week of May 28, 2018.