News

Earlier this year, The Center for Biosimilars® staff sat down with our editorial advisory board member, Ivo Abraham, PhD, RN, director of the Center for Health Outcomes and PharmacoEconomic Research at the University of Arizona Cancer Center. In the interview, Abraham discussed how biosimilars have progressed in the United States over the past year, whether biosimilars are indeed delivering on their promised cost savings, and challenges that still lie ahead in the cancer space.

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 Canadian Association of Gastroenterology and Crohn’s and Colitis Canada this week announced a joint statement on biosimilars in the treatment of inflammatory bowel disease (IBD). The paper, which is slated to appear in the Journal of the Canadian Association of Gastroenterology, recommends that patients stable on biologic treatment should not be subject to nonmedical switching, and recommends against automatic substitution of biosimilars for their references.

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

During the United European Gastroenterology Week 2019, held October 29-23 in Barcelona, Spain, researchers from Celltrion presented pooled data from 3 postmarketing studies of CT-P13 in patients with inflammatory bowel disease (IBD) that underscore the safety of the biosimilar.

A new research report from Milliman, commissioned by the Leukemia and Lymphoma Society (LLS), found that fewer than half of patients with blood cancer received treatment within 3 months of diagnosis, and LLS says that costs may be keeping patients from getting care.

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.

Republicans in the House of Representatives this week laid out their alternative to the Affordable Care Act (ACA) in an effort to position themselves against various Democratic healthcare proposals. The document contains many ideas that have been debated previously when Republicans tried to repeal the ACA, and it draws on work from the Heritage Foundation and the Cato Institute.

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.

While providers are increasingly comfortable with switching patients with inflammatory bowel disease (IBD) from reference biologics to biosimilars on the basis of a wealth of reassuring data on the safety and efficacy of such transitions, there are fewer data available about switching among multiple biosimilars of the same reference.

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.

Therapeutic drug monitoring is of particular importance in optimizing treatment for patients with inflammatory bowel disease (IBD) who are receiving therapy with anti–tumor necrosis (anti-TNF) drugs like adalimumab. This week, during the United European Gastroenterology (UEG) Week 2019 meeting, held in Barcelona, Spain, researchers will present new findings on monitoring serum trough levels of Samsung Bioepis’ biosimilar adalimumab, Imraldi, in patients with IBD.

In December 2018, biosimilar developer Amgen announced that it had submitted its proposed infliximab biosimilar, ABP 710, referencing Remicade, to the FDA for review. A regulatory decision is expected shortly, and last week, researchers published detailed results from the biosimilar’s phase 1 clinical study that evaluated the pharmacokinetic (PK) similarity of the biosimilar with its reference.

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.

During the United European Gastroenterology Week 2019 meeting, held in Barcelona, Spain, researchers presented results of a phase 1 pivotal study of a subcutaneously administered formulation of biosimilar infliximab, CT-P13 (Remsima, Inflectra), in patients with inflammatory bowel disease (IBD).

Are you ready for the upcoming 2020 transition of insulins and other therapeutic proteins to US regulation as biologics and biosimilars? Find out what you need to know about the regulatory change with a new ebook from The Center for Biosimilars®.

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.

In a memorandum in support of its motion to dismiss the suit, AbbVie says that the complaint seeks to “upend the well-settled balance between the patent and antitrust laws,” that the complaint would end international early-entry patent settlements that do not have the same global market entry date, and that it would “chill medical and therapeutic innovation.”

Representatives Paul Tonko, D-New York, and Rob Gibbs, R-Ohio, have introduced H.R. 4629, the Star Ratings for Biosimilars Act, in the House. The bipartisan bill would require HHS to evaluate Medicare Advantage (MA) plans based on whether biosimilars are available to enrollees.

The less experience an oncologist has with administering rituximab, the more likely a Medicare beneficiary with non-Hodgkin lymphoma is to discontinue treatment, according to a new study. In addition, early rituximab discontinuation was associated with inferior lymphoma-specific and overall survival.

The Japanese Adverse Drug Event Report (JADER) database, a large, published database managed by the Pharmaceuticals and Medical Devices Agency for pharmacovigilance, collects spontaneous reports as a means to detect adverse events (AEs) related to drugs, and a newly published study used the JADER data to assess AEs related to the reference infliximab and to the biosimilar, CT-P13.