Business

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.

As biosimilars for innovator biologics advance, drug makers are seeking new indications for products in their portfolios as a means to protect their sales against oncoming—or existing—competition. This month saw 3 notable label developments for drugs made by Janssen, Alexion, and AbbVie.

When it comes to considering using biosimilars, savings for patients are providers’ top concern, followed by savings to the healthcare system at large. Yet physicians also rate their own confidence levels in biosimilars as a main hurdle for widespread biosimilar adoption.

The Center for Biosimilars® recaps the top stories for the week of October 21, 2019.

Writing in a viewpoint in JAMA, Walid F. Gellad, MD, MPH, and Chester B. Good, MD, MPH, both of the University of Pittsburgh, argue that the deep cost savings achieved in Europe for biosimilar adalimumab are unavailable to the United States because of settlements struck between AbbVie and the developers of all FDA-approved biosimilars.

The World Health Organization (WHO) and the International Generic and Biosimilar Medicines Association (IGBA), an umbrella organization with members including the Association for Accessible Medicines, Medicines for Europe, and a number of other national and regional generic and biosimilar organizations, have signed a memorandum of understanding.

A recent survey of employers regarding their concerns about growing healthcare costs reveals that some are looking to biosimilars as one method of controlling specialty drug spending.

While some data suggest that overall drug price increases may have moderated recently, prices for specific drugs continue to rise at rates above inflation.

On Friday, Humana filed a lawsuit in the Eastern District of Pennsylvania, alleging that 37 defendants engaged in a “far-reaching conspiracy” to “blatantly fix the price” of generic drugs.

Drug maker Pfenex announced this week that it has completed its comparative use human factors study for its follow-on teriparatide product, PF708, referencing the osteoporosis drug Forteo.

H.R. 3, The Lower Drug Costs Now Act, passed 2 committees in the House of Representatives Thursday, with a bipartisan amendment intended to boost uptake of biosimilars tucked inside.

Yesterday, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion of Mundipharma’s pegfilgrastim biosimilar.

A trio of employer groups has formed a new partnership to advocate for policies that address the problem of high—and growing—drug costs.

The Center for Biosimilars® recaps the top stories for the week of October 14, 2019.

NeuClone said Thursday that it has begun dosing participants with its proposed ustekinumab biosimilar, referencing Stelara, in a phase 1 trial.

The Belgian Competition Authority, which contributes to implementing Belgium’s competition policy by addressing anticompetitive practices, announced that it is conducting inspections of some drug makers suspected of having implemented “restrictive practices aimed at limiting, delaying or even preventing the entry into the market or the expansion of biosimilar medicines competing with existing medicines."

As innovator biologics that have achieved blockbuster sales status reach or near the end of their exclusivities, biosimilar competition is close behind. This week, stakeholders got a closer look at how innovator drug companies are positioning themselves to maintain their sales in the face of such competition.

Drug shortages are an increasing problem—witness the news this week that the chemotherapy drug vincristine, a mainstay in fighting pediatric cancer, is in such short supply that doctors may be forced to start rationing, according to published reports. On Wednesday, the FDA said fiscal year 2018 saw a record number of generic drug approvals.

Genentech has announced that a phase 3 study of its brand-name rituximab, Rituxan, met its primary end point and demonstrated that treatment with rituximab is superior to treatment with mycophenolate mofetil in patients with moderate to severe pemphigus vulgaris (PV), a rate autoimmune disease that affects the skin and mucous membranes.