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In an interview with The Center for Biosimilars®, Angus Worthing, MD, FACP, FACR, chair of the American College of Rheumatology (ACR) Government Affairs Committee, discussed the letter recently sent to HHS addressing physician concerns with proposed legislation.

Under the original proposed formulary change, adult patients currently taking the reference infliximab would be switched to the biosimilar.

Korea's Ministry of Food and Drug Safety granted marketing approval to the biosimilar on March 17, to be sold as Eucept.

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.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of March 12, 2018.

Biosimilars of eculizumab, which have the potential to reduce costs for both patients and the healthcare system, have been eagerly awaited, yet many drug makers are developing novel anti-C5 agents.

This week, Israel-based Protalix BioTherapeutics, Inc, announced positive results from a phase 2 clinical trial for its orally administered anti–tumor necrosis factor (anti-TNF) drug, OPRX-106, a plant cell–expressed recombinant human TNF receptor II fused to an IgG1 Fc domain.

Between 2013 to 2015, doctors at St. Petersburg City Hospital 15 wrote out prescriptions for 34 packages of the 500-mg dose and 31 packages of 100-mg dose, and the suspects allegedly then sold the stolen drugs for a total of around $51,000.

The IQVIA Institute for Human Data Science (formerly the IMS institute) has released a new report making predictions for the healthcare landscape in 2018 and beyond, and the report’s authors see biosimilars as having a key role in developed markets in the years ahead.

The biosimilar was developed by Dr Reddy’s Laboratories and first approved in India in 2007. A collaboration was announced in 2016 of Dr Reddy’s and TRPharm, under which TRPharm will register and commercialize a total of 3 biosimilar products of Dr Reddy’s in Turkey.

Coherus has announced that it sees the potential for a mid-year launch of its pegfilgrastim biosimilar.

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.

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 top 3 pharmacy benefit managers by market share will now be owned by insurers, whereas a year ago, only 1 was.

Not all stakeholders are convinced that UnitedHealthcare's newly announced change of policy is enough to offset the role that pharmacy benefit managers have had in rising out-of-pocket costs for consumers.

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.

Merck, operating under the trade name MSD in the European Union, announced today that it has launched Samsung Bioepis’ biosimilar trastuzumab, Ontruzant, in the United Kingdom.

“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.

Among commercial plans covering employees and their families, said Express Scripts, drug spending increased by just 1.5% per person, down from 3.8% in 2016. Calling this rate a “historic low,” Express Scripts said that this level of spending growth is the lowest that it has measured since 1993.

The trastuzumab biosimilar is priced 29.5% below the list price for the trastuzumab reference product, Herceptin.

On March 2, UK Prime Minister Theresa May delivered a speech on the future of the United Kingdom’s relationship with the European Union, calling for the United Kingdom to remain a member of the European Medicines Agency (EMA), and saying that the United Kingdom could commit to abiding by the rules of the EMA and “making an appropriate financial contribution” to the agency.

The proposed biosimilar references Genentech’s Pulmozyme, a biologic first approved in the early 1990s in both the European Union and the United States. Pulmozyme is used in conjunction with other therapies to improve pulmonary function in patients with cystic fibrosis.

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.

The FDA and the European Medicines Agency announced today that the mutual recognition agreement on good manufacturing practice (GMP) inspections between the European Union and the United States now includes 4 additional EU member states.

India-based drug manufacturer Cadila Healthcare has announced that it is planning to file a Biologics License Application (BLA) for its biosimilar pegfilgrastim with the FDA by the end of 2019. To date, no developer has been successful in gaining regulatory approval in the United States or European Union for a biosimilar of the reference pegfilgrastim.

The American College of Rheumatology (ACR) has updated its health policy statements for 2018, and biosimilars featured heavily in the organization’s concerns for the year ahead.

Over the past 2 years, commercially insured patients enrolled in plans that had value-based contracts for certain high-cost drugs had lower copays for their medications than did patients enrolled in plans without such contracts. That finding comes from “Delivering Results for Patients: The Value of Value-Based Contracts,” a new report from the Pharmaceutical Research and Manufacturers of America (PhRMA).

The US Patent Trial and Appeal Board (PTAB) has decided that the Saint Regis Mohawk Tribe cannot claim sovereign immunity from inter partes review (IPR) of Allergan’s patents covering Restasis, and that the IPR proceedings on those patents can continue with Allergan as the patent owner.