Policy

Some industry groups have begun voicing their concerns that proposed tariffs could have a negative effect on the production of generics and biosimilars, and may increase the cost of these products.

The financial plan, which is revised each year, outlines the financial position of the Biosimilar User Fee Act program over the next 5-year authorization period, and explains how the FDA will allocate resources to build its biosimilars review program.

The Center for Biosimilars® recaps the top 5 biosimilars articles for the week of April 2, 2018.

In a briefing to regional committees, the United Kingdom's National Health Service (NHS) urged commissioners to begin planning to use the best-value adalimumab option beginning in October 2018, when Amgen’s EU-authorized biosimilar, Amgevita, becomes available.

In the rule, CMS said that it would lower the maximum co-pay amount for low-income subsidy (LIS) beneficiaries for biosimilar and interchangeable biosimilars to match the lower co-pay amount required for generic and preferred multiple-source drugs.

Last week, Senator Claire McCaskill, D-Missouri, together with the minority staff of the Senate Homeland Security and Government Affairs Committee (HSGAC), released a report on prescription drug price increases that affect the 20 products most commonly prescribed to seniors.

“A [3]-year time lag for the next biosimilar medicine, from market authorization to the patient switching process, should not occur," say the authors of a recent review.

The Center for Biosimilars® recaps the top 5 biosimilars articles for the week of March 26, 2018.

One of the more serious concerns the FDA has discussed is the possibility that a developer of a proposed biosimilar could be deterred from seeking approval of its product, because United States Pharmacopeial Convention's (USP) proposed changes could complicate the licensure of a proposed biosimilar that meets the approval requirements of the FDA but does not match the USP’s standards of a monograph.

On Monday, March 26, a Delaware court judge granted Coherus Biosciences’ motion to dismiss a lawsuit brought by Amgen over alleged infringement of a patent covering pegfilgrastim (Neulasta).

FDA Commissioner Scott Gottlieb, MD, indicated that the agency would be putting forward policies that would compel branded drug makers to “tighten up their manufacturing, to have less variance of their biologics that are currently on the market.” In theory, this change could make it easier to develop a biosimilar using smaller studies.

A new brief from Avalere Health argues that, if a multisource market for biologic drugs is to emerge in the United States, originator biologics and biosimilars must be able to gain market share commensurate to the value they offer to the healthcare system, and a variety of policy options are available to create the necessary conditions for true competition.

While biosimilars have made significant inroads into the European marketplace, there remain hurdles to the adoption of these lower-cost drugs, especially in lower-income nations; external reference pricing can mean that drugs are priced to wealthier European countries’ financial capabilities, and manufacturers’ launch strategies may bring biosimilars to nations with the greatest market potential first.

Approximately 80% of Americans think that the cost of prescription drugs is unreasonable, and 73% believe that pharmaceutical companies are making too much profit on their products.

Earlier this week, President Donald Trump made a speech in New Hampshire to discuss the administration’s efforts in combatting both the opioid crisis and high drug prices. In the speech, Trump alluded to a possible press conference in the near future that would discuss potential proposals in reducing prescription drug prices.

The Center for Biosimilars® recaps the top 5 biosimilars articles for the week of March 19, 2018.

Insurance lobbying group, America’s Health Insurance Plans (AHIP), recently named Matt Eyles as its next president and CEO beginning June 1. Eyles, currently AHIP’s chief operating officer, recently gave a statement about his priorities for the organization once he begins his tenure.

House Bill 4005 requires drug manufacturers to compile a report on a prescription drug if the price was $100 or more for a 1-month supply (or course of treatment lasting less than 1 month) and if the net price increased by 10% or more.

This week, the Spanish Society of Digestive Pathology (SEPD) became the most recent organization to announce an updated position statement on the use of biosimilars.

Yesterday, 9 physician groups sent a joint letter to HHS Secretary Alex Azar in which they voiced concerns about the President’s 2019 Budget and the Council of Economic Advisers’ drug plan.

The number of patent settlements that limit generic drugs' market entry and involve a transfer of value (monetary or otherwise) for the delay of entry have stabilized at a low level, says the European Commission.

"The pharmacist remains a very important member of the healthcare team that has the ability to explain to the patient the differences between the biologic and the biosimilar. It is the pharmacist–patient relationship that will assist the patient in making the best decisions to obtain the optimal clinical outcome," said Larry D. Wagenknecht, PharmD, FMPA, FAPhA, CEO of the Michigan Pharmacists Association.

This week, Senators Tom Cotton, R-Arkansas, and Claire McCaskill, D-Missouri introduced the Preserving Access to Cost-Effective Drugs (PACED) Act in response to Allergan’s recent transfer of its patents covering its dry-eye drug, Restasis, to the Saint Regis Mohawk Tribe in exchange for the Tribe’s invocation of sovereign immunity against inter partes review.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of March 5, 2018.

Green Shield Canada (GSC), a not-for-profit health benefits company that offers employee group health benefits that supplement government-sponsored provincial health plans, has announced a new program to switch patients to biosimilar therapies.

Gillian Woollett, MA, DPhil, senior vice president of Avalere and leader of the company’s FDA practice, told The Center for Biosimilars® in an interview that a study she co-authored is aimed at reassuring all biosimilar stakeholders that, “even though no clinical differences are expected when patients are switched from a reference product to a biosimilar, indeed none are found. Hence, we confirm the expectation already established through the application of sound regulatory science.”

“You can’t have your cake—or in this case, your rebates—and a vibrant market for biosimilar competition too,” said FDA Commissioner Scott Gottlieb, MD.

The law, which was passed with broad bipartisan support in both the Michigan House and Senate, allows for biologics designated by the FDA as interchangeable to be substituted at pharmacies with appropriate communication of the substitution to both patients and physicians.

The Canadian Agency for Drugs and Technologies in Health, the Canadian entity responsible for health technology assessments, has announced that it has revised its approach to reviewing biosimilars.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of February 26, 2018.