News

Today, at the 13th Congress of the European Crohn’s and Colitis Organisation (ECCO), researchers released 12-month data from the Personalized Anti–Tumor Necrosis Factor (anti-TNF) Therapy in Crohn Disease (CD) Study (PANTS).

Scott Gottlieb, MD, Commissioner of the FDA, is calling for changes to biosimilar regulation to help facilitate biosimilar approval, market entry, and competition.

This week, the American Society of Clinical Oncology (ASCO) released a new statement that seeks to offer clinicians guidance on the use of biosimilars in oncology as a wave of patent expirations is expected to bring more anti-cancer and supportive care biosimilars to the US market.

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

The TITRATE study is designed to investigate whether intensive management of RA leads to a greater number of remissions at 12 months, in addition to examining levels of disability, quality of life and acceptability, and cost-effectiveness.

Ireland’s Minister for Health, Simon Harris, announced this week that Ireland is seeking to join Belgium, the Netherlands, Luxembourg, and Austria in their BeNeLuxA Initiative, a group that negotiates price deals on pharmaceuticals directly with manufacturers.

A study recently published in the European Journal of Hematology reports diffuse large B-cell lymphoma (DLBCL)–specific findings from MONITOR-GCSF, a pan-European, multicenter, prospective, observational study that attempts to describe the treatment patterns and clinical outcomes of patients who received biosimilar filgrastim in the prophylaxis of chemotherapy-induced neutropenia and febrile neutropenia.

Yesterday, Eli Lilly announced that its anti–IL-17 monoclonal antibody ixekizumab (Taltz) met the primary and key secondary endpoints in the phase 3 COAST-V trial evaluating its safety and efficacy in ankylosing spondylitis.

According to Roy Fleischmann, MD, a recent American College of Rheumatology (ACR) white paper appropriately describes issues including the nomenclature of biosimilars, the biosimilar approval pathway, and differences between biosimilars for biologic drugs and generics for small-molecule drugs. However, he takes issue with ACR's stance on substitution, extrapolation, and interchangeability.

Celltrion’s head of strategy and operations, Ho Ung Kim, told reporters this week that the intravenous Herzuma could be launched at as much as a 50% discount to a subcutaneously administered presentation of the reference Herceptin.

Roche has released positive phase 2 data for its proposed novel anti–vascular endothelial growth factor and anti–angiopoietin-2 bispecific antibody, RG7716.

Yesterday, President Trump released his budget proposal for the 2019 fiscal year. On the same day, the Proceedings of the National Academy of Sciences of the United States of America released a paper summarizing the NIH’s contribution of funding to new drugs approved from 2010 to 2016.

Researchers found that the biosimilar offered only limited efficacy when used for induction of remission in patients with moderate to severe ulcerative colitis that was refractory to treatment with steroids.

This past November, the US Supreme Court heard oral arguments in a case that may dramatically affect how patents covering biologic drugs are litigated: Oil States Energy Services, LLC v Greene’s Energy Group, LLC.

Some case reports have suggested that rituximab can effectively treat nephrotic syndrome, and a recent study sought to assess the safety and effectiveness of rituximab in treating patients who have steroid- and cyclosporine-resistant pediatric nephrotic syndrome.

South Dakota Senate Bill 75, a biosimilar substitution bill, is expected to be signed by South Dakota’s Governor, Dennis Daugaard-R.

On Friday, the White House’s Council of Economic Advisors (CEA), an agency within the Executive Office of the President, released a white paper titled “Reforming Biopharmaceutical Pricing at Home and Abroad.”

“It is likely that the remediation by Celltrion of the issues addressed in the warning letter will result in a delayed approval of the biosimilar products by the FDA,” Teva told investors.

Novartis announced on Thursday that the FDA has approved a label update for secukinumab (Cosentyx) to include moderate to severe scalp psoriasis, a particularly challenging form of psoriasis to treat, and a condition that affects approximately half of patients with psoriasis.

With a new budget bill having been signed by President Trump, the second government shutdown of 2018 is now over. The Bipartisan Budget Act of 2018 contains several provisions of interest to biosimilars stakeholders.

According to the recently released Personalized Medicines Coalition 2017 Progress report, the FDA approved a record number of 16 new personalized medicines in 2017.

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

The Federal Circuit on Monday affirmed a previous district court dismissal of drug maker AbbVie’s suit against MedImmune Limited over US Patent 6,248,516 (“the ’516 patent”).

In late 2017, a study was published in Acta Reumatologica Portuguesa evaluating the effect adalimumab (Humira), an anti–tumor necrosis factor therapy in the treatment of patients with both short- and long-term psoriatic arthritis (PsA) disease duration.

The American College of Rheumatology (ACR)'s previous position on biosimilars was one of caution during the initial development, evaluation, and approval of these drugs, but, writes the organization, “Now that biosimilars have been used successfully in Europe, with rigorously acquired data supporting their broader use, and as the [United States] is on the verge of a similar transition, the ACR is poised to reconsider its position.”

Recently, the pan-Canadian Pharmaceutical Alliance (pCPA) annonced that it has reached a deal with generic drug makers to cut the prices of dozens of popular medications in exchange for an agreement that no jurisdiction will move to a system of public tendering for its drugs. In addition to the nationwide generic price cut, the province of Quebec also announced that it is the most recent Canadian area to add biosimilar etanercept (Erelzi) to its formulary.

YL Biologics, a partnership forged between Lupin Pharmaceuticals and Yoshindo Inc to develop and market biosimilar therapies, has announced the successful completion of a global, phase 3 clinical trial of its proposed etanercept biosimilar, YLB113.

Managed care professionals can assist ophthalmologists and retina specialists in personalizing anti-vascular endothelial growth factor (anti-VEGF) treatment to encourage patient adherence, according to a recent review of the literature on this topic.

The fourth-quarter and full-year 2017 earnings report from Amgen highlights the fact that biosimilars can be both a challenge and an opportunity for drug makers whose innovator products face biosimilar competition and who develop biosimilar products of their own.

Because serum tumor necrosis factor (TNF) is high in patients with Kawasaki disease (KD), infliximab, an anti-TNF agent, has been proposed as a potential treatment for refractory KD, but few randomized trials have been conducted to demonstrate the efficacy and safety of using infliximab in this setting.