Policy

During the 34th International Conference on Pharamcoepidemiology and Therapeutic Risk Management, taking place from August 22 to 26 in Prague, Czech Republic, researchers will present findings that contrast the cost savings made possible by biosimilars in the US and European contexts.

The National Institute for Health and Care Excellence (NICE) evidence reviewers considered a biosimilar discount of 70% to 90% off the reference trastuzumab’s price at a 90% to a 100% market share, and the Cancer Drugs Fund provided the committee with confidential information on the weighted average price and market share for available biosimilar trastuzumab products.

Although the policy change was intended to cut out-of-pocket drug costs for patients, a number of organizations, including the American College of Rheumatology (ACR), have argued that step therapy can be harmful to patients with chronic conditions. On Wednesday, ACR met with HHS Secretary Alex Azar to discuss their concerns.

The Center for Biosimilars® recaps the top news for the week of August 13, 2018.

Eli Lilly says that it will not comply with a 2017 California law on drug pricing, and now the state senator who sponsored the bill is hitting back against the drug manufacturer, calling the company’s activities to promote its diabetes programs “disingenuous and offensive.”

Clinical director of the Irish health technology assessment (HTA) body National Centre for Pharmacoeconomics (NCP), Michael Barry, MB, FRCPI, PhD, recently said in an interview with Irish media that the lack of uptake of biosimilars in Ireland is “an issue that should be tackled,” and he proposed approaches to do just that.

The district court for the Eastern District of Pennsylvania has denied Johnson & Johnson’s motion to dismiss an antitrust civil action brought by Pfizer over infliximab.

The Center for Biosimilars® recaps the top 5 articles for the week of August 6, 2018.

CMS this week announced a policy that will allow Medicare Advantage (MA) plans to negotiate drug prices for physician-administered and other Part B drugs by allowing plans to employ the utilization management strategy known as step therapy to newly diagnosed patients.

Express Scripts framed its formulary as a response to pharma: “Despite promises to limit price increases, drug makers are trying to game the market by delaying generic competition, blocking access to safe and effective biosimilars, and coyly deferring—not cancelling—list price increases,” it said.

The government has launched a consultation that outlines the proposed changes to its price controls, which require brand-name drug makers to pay the government 7.8% of their sales of products to the National Health Service.

The Institute for Clinical and Economic Review (ICER) explains that, compared with anti–tumor necrosis factor (anti-TNF) drugs, both guselkumab and risankizumab offered a superior benefit based on currently available data.

The Initiative for Medicines, Access, and Knowledge (I-MAK), a public interest team of attorneys and scientists who seek to ensure that patents do not obstruct patient access to affordable medicines, has issued a new report that details the number of patents drug makers have attempted to secure for the highest-grossing drugs in the United States.

The Center for Biosimilars® recaps the top 5 articles for the week of July 30, 2018.

This week, the European Medicines Agency (EMA) announced that it will scale back and even fully suspend a number of its activities in order to cope with Brexit-related pressures, and as the possibility grows stronger that the United Kingdom and the European Union may not reach a trade agreement, some drug makers have begun to stockpile key medicines to help guard against a supply disruption.

NHS Improvement, the body that oversees the financial stability, quality, and operational performance of England’s National Health Service (NHS) trusts, reports that switching patients to biosimilars and generics of high-cost drugs led to £324 million ($424 million) in savings in the last financial year, and that it could benefit from an additional £100 million ($131 million) in savings this financial year from greater biosimilar use.

The Association for Accessible Medicines (AAM) has released the 10th edition of its annual Generic Drug Access and Savings Report that provides an outline of the savings generated by generics and biosimilars in the past year.

The World Health Organization (WHO) has produced a draft Question and Answer (Q&A) document that gives additional clarification to its 2009 guidelines for evaluating similar biotherapeutic products, particularly with respect to evaluating biosimilars of monoclonal antibodies.

This month, the Maine legislature authorized a bill titled “An Act to Require Drug Manufacturers to Comply with Federal Law,” or 2017 ME S 432, which seeks to combat the misuse of Risk Evaluation and Mitigation Strategy (REMS) programs within the state.

This week, a federal appeals court declined to hear a petition to rehear a challenge by the Association for Accessible Medicines to a Maryland drug pricing law.

The Center for Biosimilars® recaps the top 5 articles for the week of July 23, 2018.

“It’s one thing for us to get the biosimilar approved and go through all of that,” said Juliana M. Reed, corporate affairs global biosimilars lead for Pfizer. “That was the early conversation of the market developing. Now the market needs to be accessible.”

On the whole, the FDA’s plan, says Robert Cerwinski, JD, is “net good news for the biosimilar developers,” and should provide “tailwinds” for the industry by giving greater clarity, streamlining processes, and reducing the time and expense that biosimilar developers will need to bring their products to the marketplace.

Yesterday, Congressman John Sarbanes, D-Maryland, introduced the Biosimilars Competition Act of 2018 in the United States House of Representatives. The bill would require biologic and biosimilar drug manufacturers to report any agreements they enter into that may keep lower-cost drugs from reaching consumers.

According to the report, Medicare Part D drugs that demonstrated the lowest annual cost increases offered higher average rebates than drugs with the highest annual cost increases.

Last week, drug manufacturer Merck announced that it will be taking part in several strategies to establish “responsible pricing” going forward, joining the ranks of some of the latest companies taking similar actions, including Novartis and Pfizer.

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.