Business

The American Medical Association (AMA) wants medical schools and residency programs to start training medical students and residents in healthcare economics.

In an interview with The Center for Biosimilars®, Sandoz’s Sheila Frame, MBA, vice president of marketing, market access, and patient services, and William Yoon, PharmD, MBA, head of external engagement and medical advocacy, reflected on the past decade of experience with the biosimilar pathway and gave a look at the future of Sandoz’s biosimilar efforts.

The Center for Biosimilars® recaps the top stories for the week of November 18, 2019.

Perhaps not surprisingly, officials from generic drug companies, reference product companies, the FDA, and the Federal Trade Commission (FTC) have different opinions about the usefulness of various actions the federal government has taken to prevent abuses of risk evaluation and mitigation strategies (REMS), according to a recently released Government Accounting Office (GAO) report.

This month, the European Commission’s Pharmaceutical Committee, part of the Health and Food Safety Directorate-General, updated EU member states as to the results of a targeted consultation it undertook in 2018 on a specific type of duplicate marketing authorization applications (MAAs) for originator biologics and their potential impact on biosimilars.

Samsung Bioepis announced Tuesday that the FDA has accepted for review the company’s Biologics License Application (BLA) for SB8, a proposed bevacizumab biosimilar referencing Avastin. The biosimilar developer submitted the BLA in September.

While much attention over the past few weeks has been on the US biosimilars market, with its recent approvals and product launches, Canada has also been making strides in its own biosimilars experience.

Novartis has confirmed in an email to The Center for Biosimilars® that it has launched Sandoz’s pegfilgrastim biosimilar, Ziextenzo, in the United States. According to Novartis, the wholesale acquisition cost (WAC) for Ziextenzo is $3925, or an approximate 37% discount off the WAC for the reference product, Amgen’s Neulasta.

The AARP Public Policy Institute has released a new Rx Price Watch report showing that, last year, the retail prices of 267 brand-name drugs that are commonly used by older Americans rose by an average of 5.8%—more than twice the general rate of inflation, which was 2.4%.

The Center for Biosimilars® recaps the top stories for the week of November 11, 2019.

The World Health Organization (WHO) this week announced its pilot procedure for the prequalification of human insulin as means to facilitate access to safe, effective, and quality-assured insulin and insulin biosimilars for type 1 and type 2 diabetes in low- and middle-income countries.

Improvements in biosimilars—ones that may give them an advantage such as lower immunogenicity or a new route of administration—may be the key to unlocking a better patient experience, according to Celltrion. In fact, pursuing such so-called “biobetters” may prove to be more important for the drug maker than pursuing interchangeable biosimilars.

During the FT Global Pharmaceutical and Biotechnology Conference, held this week in London, United Kingdom, a panel of executives from pharmaceutical companies, together with a scientist whose focus is on economics, discussed the increasingly challenging problem of paying for innovative therapies, particularly in a context of heightened political pressure around high drug costs.

Postmarket drug price changes alone accounted for most of the recent spending growth on biologics, and manufacturers’ rebates had little impact, according to an abstract presented at the American College of Rheumatology’s 2019 meeting, being held in Atlanta, Georgia, this week.

The great promise of biosimilars is their ability to provide high-quality treatment at a reduced cost, thereby producing cost savings that can be reapplied. But how are healthcare systems around the globe utilizing those cost savings? During the International Society for Pharmacoeconomics and Outcomes Research 2019 meeting, held this week in Copenhagen, Denmark, several teams of researchers reported on how biosimilars are impacting international markets, and how they could provide headroom for new, expensive treatments.

The Center for Biosimilars® recaps the top stories for the week of November 4, 2019.

Teva and Celltrion have announced the launch of their biosimilar rituximab, Truxima, in the United States. The product is being offered at a 10% discount to the list price of reference product, Rituxan. The product will begin to reach patients on November 11.

This week, multiple biosimilar developers announced major moves forward for their businesses, with Coherus BioSciences making a new acquisition, Celltrion reporting continued growth for its business, Bio-Thera Solutions gaining the first-ever approval of an adalimumab biosimilar from China’s National Medical Products Administration, and Alvotech and Stada entering into a 7-biosimilar partnership in Europe.

Samsung Bioepis announced Wednesday that it has entered into a new commercialization agreement with partner Biogen for 2 ophthalmology biosimilars that are currently in development.

The FDA has issued an establishment inspection report (EIR) for Biocon’s Bengaluru facility, where the drug maker manufactures biosimilars, and the FDA’s inspection of the facility, which took place during August 2019, is now closed.

France has experimented with financial incentives to reward the prescribing of biosimilars. These incentive structures include shared savings for centers that acquire medicines at lower costs, as well as biosimilar prescribing targets.

The biggest cost difference in filgrastim administrations was seen in the commercially insured population after the launch of a biosimilar, according to a study published Monday in Health Affairs.

UnitedHealthcare has revised its community and commercial plans’ coverage of erythropoiesis-stimulating agents. Effective January 1, 2020, patients who are receiving the reference epoetin alfa, Epogen or Procrit, will be required to switch to Pfizer’s biosimilar, Retacrit.

In a research letter appearing this week in JAMA Internal Medicine, authors from Oregon Health and Science University raised the question of whether the “large and increasing revenue from eculizumab” could be tied to off-label use for non-approved indications.

In its third quarter 2019 financial results, AbbVie, maker of the blockbuster Humira, said that its international revenues for the brand-name adalimumab were $1.049 billion, or a decrease of 33.5% on a reported basis, after having faced competition from biosimilars.

The Center for Biosimilars® recaps the top stories for the week of October 28, 2019.

Given how markets operate, pharmaceutical companies need financial incentives in order to keep providing a reliable stream of high-quality products that otherwise, due to low prices and other factors, might fall into shortage, according to an FDA report about the drug shortages problem released this week.

Biosimilars are beginning to gain momentum, even in the sluggish US market, evidenced by strong US and global sales reported this month by some of the top biosimilar players.

Drug maker Revance Therapeutics has announced positive results from its SAKURA clinical program for its daxibotulinumtoxinA, a novel botulinum toxin type A that it hopes will compete with brand-name Botox, or onabotulinumtoxinA.

Drug maker Formycon announced today that it has begun a phase 1 clinical trial of its proposed ustekinumab biosimilar, FYB202, referencing Stelara. Ustekinumab is the first available therapy to target the interleukin-12 and -23 pathway.