Samantha DiGrande

Experts from Venable, Alkermes, and Novartis provide updates to the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and explain the differences between inter partes review (IPR) and post grant review (PGR) litigation.

During the first day of the SMi Biosimilars Meeting held in Iselin, New Jersey, from November 14-15, 2018, Christina Yunis, global biosimilars market development lead at Pfizer, discussed the sustainability of and challenges seen in the biosimilars market from an industry perspective.

Pfizer announced today that it has launched its epoetin alfa biosimilar, Retacrit, at a substantial discount to the reference product, Epogen.

Innovent Biologics, a China-based biopharmaceutical company, announced that its new drug application for its proposed adalimumab biosimilar IBI303, referencing Humira, was accepted by the National Medical Products Administration.

When treating any disease, adherence is key. Specifically, however, in inflammatory bowel disease (IBD), adhering to biologic therapy is critical in the management of these diseases, as previous research has demonstrated that a medication possession ratio (MPR) of less than 0.86 significantly increases the risk of disease flare.

Genentech says that the biosimilar company benefited from its proprietary information, and a hearing is scheduled for December 13, 2018.

During the Community Oncology Alliance Payer Summit, held October 29-30, 2018, The Center for Biosimilars® had the opportunity to sit down with several oncologists to discuss their opinions on and experiences with biosimilars.

After the votes from the midterm elections were counted Tuesday and the Democrats had gained a majority in the US House of Representatives while Republicans reinvigorated their hold on the Senate, it was clear that a hot topic on voters’ minds was the high cost of drugs in the United States; however, questions remain as to what the newly elected officials will be able to accomplish to reduce prices.

According to the earnings report, aflibercept sales in the United States increased 7% to $1.02 billion versus third quarter 2017 results.

Elaine Herrmann Blais, partner; Scott Lassman, partner; and Alexandra Valenti, associate at Goodwin, covered 3 areas of topics ranging from the Biologics Price Competition and Innovation Act litigation, updates on the Patent Trial and Appeal Board, and recent regulatory and FDA issues related to biosimilars.

Amgen filed a cross appeal in this long-running case on October 15, 2018. The appeal challenges, among other things, the district court’s previous judgement that Hospira had not infringed on another patent named in the original suit, US Patent Number 5,756,349, which covers the production of erythropoietin.

In a recently published bipartisan report, representatives Diana DeGette, D-Colorado, and Tom Reed, R-New York, co-chairs of the Congressional Diabetes Caucus, released findings from a year-long inquiry into the sources of ever-increasing insulin prices.

In an effort to combat competition from biosimilar adalimumab products in Europe as patents covering the reference product expired last month, AbbVie, developer of Humira, is reportedly prepared to offer a substantial discount. However, many European nations have policies that require a mandatory reduction of the reference product’s list price after biosimilar entry.

On an earnings call earlier this week, Pfizer CEO Ian Read said that the company will be returning to “business as normal” on its drug pricing in January, after having agreed to hold off on price increases earlier this year following pressure from the Trump administration.

According to the United States Attorney's Office, Xanthe Lam, a principal scientist at the Roche Holding AG unit from 1986 until 2017, conspired with her husband and fellow former employee Allen Lam, and John Chan, another former Genentech employee, to steal trade secrets over the course of 5 years related to the biopharmaceutical dornase alfa (Pulmozyme) and some of Roche’s top-selling cancer drugs: rituximab (Rituxan), trastuzumab (Herceptin), and bevacizumab (Avastin).

A recent study presented at the Annual Scientific Meeting of the British Blood Transfusion Society, held in Brighton, United Kingdom from October 3-5, 2018, sought to determine the impact of introducing biosimilar filgrastim (sold in the United Kingdom as Zarzio) on the number of patients who were able to achieve target CD34 yield in peripheral blood stem cell mobilization (PBCM).

Secukinumab’s growing number of indications and its body of positive data may help it to compete for a substantial share of the inflammatory disease market against an increasing number of US- and EU-approved biosimilars, including 4 recently launched adalimumab biosimilars in the European Union.

Yesterday, the Trump administration released a new plan aimed at reducing Medicare’s costs for prescription drugs. Under the plan, CMS would be able to set its prices for some drugs, including biologics, based on the prices paid in other nations. Since the announcement, several stakeholders have spoken out about the proposed change.

This month, Maryland’s Attorney General Brian Frosh petitioned the Supreme Court to uphold the “first-in-the-nation” law against drug price-gouging.

The European Society for Medical Oncology (ESMO) 2018 Congress, held October 19-23, 2018, in Munich, Germany, featured multiple presentations on biosimilars in oncology, all of which are contributing to the body of evidence that points to the safety and efficacy of these products. Despite such reassuring data for biosimilars, however, many stakeholders have noted that lack of provider education on biosimilars is holding back progress with uptake.

As more biosimilars are earning regulatory approvals in both the United States and the European Union, the question of whether to switch patients (and at what point to do so) continues to be discussed; researchers will present findings from 2 etanercept switching studies in patients with rheumatoid arthritis (RA) during the American College of Rheumatology’s (ACR) Annual meeting, held in Chicago, Illinois October 19-24, 2018.

During the American College of Rheumatology’s Annual Meeting, held in Chicago, Illinois from October 19-24, 2018, various researchers will present findings on the safety, efficacy, and immunogenicity of 3 adalimumab biosimilars.

Genentech announced this week that the FDA has approved an update to its reference rituximab’s (Rituxan) label.

Mylan and Biocon’s biosimilar trastuzumab, which will be sold as Ogivri and which references Herceptin, today received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

As biosimilar etanercept SB4, sold in many markets as Benepali, has entered the rheumatoid arthritis treatment space, researchers have recognized the need to investigate the retention rates and disease activity scores among patients receiving SB4 and its reference.

This week, the insurer rolled out some of the changes it will be implementing in its Medicare Advantage (MA) plans as of January 1, 2019.

“When we change the rules, the market players will reorganize their businesses to fit the new world. And it will be a very different world for American drug pricing," said HHS Secretary Alex Azar.

A review was recently conducted among 2 different types of randomized clinical trials in the treatment of rheumatoid arthritis (RA): those comparing reference biologics’ efficacy versus placebo, and those comparing reference biologics’ efficacy versus biosimilars.

According to a filing made in the Republic of Korea, Samsung Bioepis has disclosed that Merck has terminated the companies' development and commercialization agreement for a follow-on insulin glargine product referencing Sanofi’s Lantus.

In June, the American Medical Association's (AMA) president Barbara L. McAneny, MD, outlined the group’s concerns during a hearing held by the California Department of Insurance stating that “The AMA has come to the conclusion that this merger would likely substantially lessen competition in many healthcare markets, to the detriment of patients,” and therefore should be blocked.