News

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.

The International Generic and Biosimilar Medicines Association (IGBA) has launched new educational materials on its website promoting awareness of and education about biosimilar products.

Former Representative Henry Waxman told The Center for Biosimilars® in an email that the CREATES Act “…tackles one of the numerous problems driving high drug prices—drug manufacturers’ use of anti-competitive tactics to block access to generic drugs.

Biosimilars have begun to erode sales of Roche’s innovator rituximab (MabThera in Europe, Rituxan in the United States), according to the drug maker’s 2017 annual report.

A cross-sectional study published in the International Journal of Clinical Pharmacy in late 2017 found that the uptake of biosimilars in the United Kingdom has been highly variable and generally lower than expected.

On January 29, the European Medicines Agency (EMA) held a joint press conference with members of the Dutch government to unveil plans for the new customized headquarters facility being built in the Zuidas business district.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of January 29, 2018.

In an interview with The Center for Biosimilars®, Angus Worthing, MD, FACP, FACR, chair of the American College of Rheumatology (ACR) Government Affairs Committee, explained the next steps for ACR after submitting a comment letter to HHS on reimbursement for Part B drug costs and prior authorizations.

During Alex Azar’s Senate confirmation hearing earlier this month, he praised pharmacy benefit managers (PBMs) and argued that they should be expanded to negotiate for physician-administered drugs in Medicare Part B.

Patients for Biologics Safety and Access, a coalition of patient advocacy organizations, called on the US Senate Committee on Health, Education, Labor and Pensions and the House Committee on Energy and Commerce to convene oversight hearings on biosimilar medicines.

Before the Wisconsin State Assembly’s health committee today is Assembly Bill 679, an act to address biosimilar substitution at the pharmacy level.

Biosimilars have reached a tipping point in the US market, according to a new drug pricing forecast from consulting company Vizient.

The FDA has issued a warning letter to Celltrion, maker of the infliximab biosimilar Inflectra. The company announced today that, on January 30, the company received a letter from the agency that “raises issues related to certain manufacturing process[es]” at its Incheon, Republic of Korea facility.

The American College of Rheumatology (ACR), which represents over 9500 rheumatologists and rheumatology health professionals, recently submitted a letter to HHS in response to the department’s request for information on Promoting Healthcare Choice and Competition Across the United States.