Policy

The FDA has approved Mvasi, the first biosimilar bevacizumab (Avastin).

Providing an overview on where the healthcare reform debate is headed, Andrew Slavitt, former head of CMS, refined the discussion to highlight the potential for biosimilars to influence the rising costs of drug products.

On Monday, the United States filed an amicus brief with the Federal Circuit in the case of Amgen v Sandoz. The brief addresses whether the Biologics Price Competition and Innovation Act (BPCIA) preempts additional remedies under state law for an applicant’s failure to comply with the so-called “patent dance.”

At the 2017 AAM Biosimilars Council Conference, Adrian van den Hoven, director general of Medicines for Europe, contradicted the conventional thinking about biosimilars, saying that biosimilars do not simply reduce costs of treatment. Instead, he said, they deliver “huge additional health benefits to patients.”

At the 2017 AAM Biosimilars Council Conference, policy experts addressed the question of how biosimilar developers can navigate the complex and challenging biologics marketplace in the United States.

Christine Simmon, senior vice president of policy and strategic alliances for the Association for Accessible Medicines (AAM) and executive director of The Biosimilars Council, told The Center for Biosimilars® at the 2017 AAM Biosimilars Council Conference that upcoming product approvals in the biosimilar space are exciting prospects not only for the industry, but, most importantly, for patients.

How can the US healthcare system learn from the European Union on market penetration for biosimilar products?

Coherus BioSciences has announced that its petition for inter partes review of AbbVie’s US Patent 9,085,619, covering the formulation of adalimumab (Humira), was not instituted by the Patent Trial and Appeal Board.

Robert Cerwinski, JD, Partner at Goodwin, discusses current infliximab litigation.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of September 4, 2017.

The US Senate’s Committee on Health, Education, Labor, and Pensions held the first 2 of its 4 full committee hearings on stabilizing the Affordable Care Act’s individual insurance market. Testifying on Wednesday and Thursday were state insurance commissioners and state governors, respectively. Across the 2 days of testimony, key themes emerged.

Maryland’s House Bill 631, which is scheduled to take effect in October 2017, is facing a lawsuit filed by the Association for Accessible Medicines, which calls the bill unconstitutional.

The FDA’s Adverse Event Reporting System, which allows healthcare professionals, patients, and others to submit reports on adverse events, contains over 8.5 million entries, a massive number complicated by the fact that any drug may be listed under an average of 16 different names.

The past weeks have seen a number of important milestones for biosimilars, from product approvals and regulatory changes to policy updates and litigation developments.

Robert Cerwinski, JD, Partner at Goodwin, discusses the potential for an upcoming executive order on drug pricing.

The European Association of Hospital Pharmacists (EAHP), a professional organization that represents over 21,000 hospital pharmacists in 35 European countries, recently released a position paper on biosimilar medicines.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of August 28, 2017.

The Lazio region of Italy had one of the lowest uptakes of biosimilars in the country. In response, specific guidance was issued for the region in November 2015.

Following the Supreme Court’s decision in Sandoz v Amgen, both drug makers have filed, in compliance with the Federal Circuit court’s order, supplemental briefs. These briefs state the parties’ opinions on the appropriate action to be taken after the Supreme Court remanded the case to the lower courts.

Ireland’s National Cancer Control Programme (NCCP) has issued new guidance on the use of biosimilar medicines in the treatment of cancer.

In recent years, drug spending has increased with the launches of new, high-cost drugs and with price hikes for established drugs. One method of controlling such increases in drug spending is reference pricing, a framework under which an insurer or employer establishes a maximum contribution that it will make toward the price of a drug or a procedure in a therapeutic class.

Robert Cerwinski, JD, Partner at Goodwin, discusses the “big 3” biologics for inter partes review: Herceptin, Rituxan, and Humira.

August saw notable developments in the market for insulins in the world of endocrinology biosimilars and follow-ons: new studies showed similarity between a challenger to branded insulin glargine; price competition gained momentum; and patients, providers, and state governments signaled an urgent need for diabetes drug prices to drop.

The National Academy for State Health Policy (NASHP), a non-profit, non-partisan academy of state health policymakers, reports the following successful 2017 drug pricing initiatives passed at the state level.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of August 21, 2017.

The United Kingdom (UK) has issued a position paper on ensuring a smooth economic transition from the European Union (EU) in relationship to the availability of goods, including pharmaceuticals.

The White House confirmed last week that it will continue to make cost-sharing reduction (CSR) payments for the month of August. The Trump administration has been making decisions on whether to continue to fund CSRs on a monthly basis, and had previously suggested that it might soon put an end to CSRs.

Despite earlier White House statements indicating that the Trump administration would ask the FDA to generate 100% of its program funding through user fee programs, on August 18, the President signed the FDA Reauthorization Act of 2017 (FDARA) into law.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of August 14, 2017.

While the FDA appears to be taking a more active role in leveraging its position to influence drug prices, the majority of efforts to bring down pharmaceutical costs are taking place at the state level.