Kelly Davio

On Friday morning in Chicago, Illinois, The Atlantic hosted a series of panels, moderated by Steve Clemons, on the role biosimilars in cancer care. Opening the morning’s proceedings were Gary Lyman, MD, MPH, co-director of the Hutchinson Institute for Cancer Outcomes Research, Fred Hutchinson Cancer Research Center, and Chadi Nabhan, MD, MBA, FACP, CMO of Cardinal Health Specialty Solutions.

Two biosimilar developers today announced that they have received positive opinions for products from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

FDA Commissioner Scott Gottlieb, MD, on Thursday announced new draft guidance documents aimed at limiting the potential for drug makers to abuse Risk Evaluation and Mitigation Strategy (REMS) requirements. The announcement comes on the heels of President Donald Trump’s drug pricing plan, which called on the agency to issue guidance on how manufacturers use REMS programs to delay competition from follow-on products.

Boehringer Ingelheim’s (BI) adalimumab biosimilar, Cyltezo, can be successfully self-administered—via auto-injector—by most patients with rheumatoid arthritis (RA).

This week, the European Commission proposed a “recalibration” of Supplementary Protection Certificates (SPCs) to boost investment in the development and manufacture of biosimilars and generics.

In a new paper, researchers sought to describe how much the European Union is overspending on neovascular age-related macular degeneration treatment by relying on ranibizumab and aflibercept rather than bevacizumab in ophthalmology.

While rituximab is frequently used off-label to treat relapsing-remitting multiple sclerosis (MS), emerging evidence suggests that patients with progressive MS may also benefit from treatment with rituximab.

This week, Drugs published a letter to the editor concerning a systematic literature review that showed a low risk of safety concerns or loss of efficacy after switching from a reference biologic product to a biosimilar. The letter’s authors said that switching is a beneficial topic for exploration but criticized the review for “over-interpretation of the available data.”

As the United States lags behind Europe and other highly regulated areas in terms of biosimilar approval and uptake, research presented during the International Society for Pharmacoeconomics and Outcomes Research 23rd Annual International Meeting in Baltimore, Maryland, points to slow market entry and small price discounts of approved biosimilar products as key factors that are holding up cost savings in the US market.

At the International Society for Pharmacoeconomics and Outcomes Research 23rd Annual International Meeting, in Baltimore, Maryland, members of the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) discussed the ways in which their organization, a not-for-profit entity that conducts postmarketing observational research to monitor biosimilars and novel biologics for efficacy and safety, is working to provide real-world evidence on these products to stakeholders.

On Tuesday and Wednesday, during the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 23rd Annual International Meeting in Baltimore, Maryland, researchers from Europe addressed the fact that, while biosimilars have a longer history in the European marketplace than they have in the United States, challenges to uptake still linger.

In a Monday workshop held at the International Society for Pharmacoeconomics and Outcomes Research’s 23rd Annual International Meeting, in Baltimore, Maryland, Mike Blum, MD, MPH, deputy director in the Office of Pharmacovigilance and Epidemiology at FDA, addressed the role of postmarketing surveillance in the US biosimilars market and the potential role of real-world evidence in interchangeable designations for biosimilars.

Today, at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 23rd Annual International Meeting, held in Baltimore, Maryland, researchers addressed the complexities of using anti–tumor necrosis factor (anti-TNF) therapy in patients with rheumatoid arthritis (RA).

Given reliance on industry fees to pay for the review of medicines, as well as the pharmaceutical industry’s potential inability to sustain the level of fees required to review all new medicines without cooperation with the European Medicines Agency (EMA), the United Kingdom could have to reduce the number of drug marketing authorizations it grants each year, or raise the funds elsewhere.

Scott Gottlieb, MD, commissioner of the FDA, who has been vocal about "shenanigans" used by innovator drug makers to forestall competition from biosimilars and generics, today announced the publication of a list of companies that have restricted access to samples of small-molecule drugs for testing through the use of Risk Evaluation and Mitigation Strategies programs or limited distribution of their products.

The American Association of Pharmaceutical Scientists (AAPS), a professional organization of 9000 scientists, has published a new white paper in The AAPS Journal that discusses the scientific and methodological considerations of the process of attribute and test method selection, criticality assessment, and assignment of analytical measures to the FDA’s 3 tiers of analytical similarity assessment for biosimilars.

Data from new CMS dashboards reveal that many of the drugs that have seen the highest annual growth in spending per beneficiary over the 2012 to 2016 period are products that either currently face or will soon face biosimilar or follow-on biologic competition.

The FDA has approved Pfizer’s biosimilar epoetin alfa, referencing Epogen. The biosimilar, epoetin alfa-epbx, which will be marketed as Retacrit, is the first biosimilar approved in 2018, and the tenth biosimilar to be approved in the United States.

Drug maker Pfenex has announced positive top-line results from a phase 3 study that showed comparable overall profiles between reference teriparatide (Forteo) and Pfenex’s proposed follow-on, PF708, in patients with osteoporosis. Teriparatide, a recombinant human parathyroid hormone, is an anabolic agent that stimulates bone formation.

At the 58th Annual Scientific Meeting of the British Society for Haematology, held from April 16-18, 2018, in Liverpool, United Kingdom, researchers from 2 hospitals reported on the use of biosimilar rituximab in real-world settings.

Mylan’s insulin glargine follow-on, MYL-1501D, referencing Sanofi’s Lantus, is a long-acting human insulin analogue that allows for once-daily basal use in patients with type 1 diabetes. The drug has been authorized for marketing as a biosimilar insulin in the European Union and in Australia under the brand name Semglee.

In an effort to accurately predict an individual patient’s response after starting or tapering an anti–tumor necrosis factor (anti-TNF) agent, researchers from the Netherlands, reporting findings in Rheumatic and Musculoskeletal Diseases, explain that calprotectin has some predictive value for clinical response in patients starting anti-TNF treatment, although it was not predictive of clinical response after tapering.

HHS’ “American Patients First” blueprint for implementing Trump’s vision includes a proposal to address the potential misuse of Risk Evaluation and Mitigation Strategy programs to delay biosimilar competition.

In an interview with The Center for Biosimilars®, Dennis Cryer, MD, physician co-convener of the Biologics Prescribers Collaborative (BPC), said, "We still feel that much of the effectiveness of therapy is the relationship and the trust that can be developed between the physician and the patient."

The United States Patent and Trademark Office (USPTO), in a proposed rule published today on the Federal Register, seeks to amend the rules for inter partes review proceedings, and similar proceedings, before the Patent Trial and Appeal Board.

Antibodies that deplete B cells, including rituximab, have demonstrated efficacy in the treatment of neurological conditions such as progressive multiple sclerosis and neuromyelitis optica spectrum disorder. The efficacy of these treatments hinges on adequate B-cell depletion, but there is a lack of standardization in treatment and monitoring protocols to guide clinical practice.

The report’s authors assessed commercial plan coverage and formulary design concerning biosimilars for the top 25 payers—covering approximately 189 million lives—in the United States, using publicly available policies.

While treatment with trastuzumab is the standard of care for HER2-positive locally advanced or metastatic breast cancer and gastric cancer, data on long-term use of the biologic are lacking, and cardiac risk related to trastuzumab has posed concerns.

Biosimilar developer Biocon has received the FDA’s Form 483 after a preapproval inspection of its Bangalore manufacturing facility resulted in 7 observations. The FDA issues Form 483 when an investigator conducting an inspection has observed conditions that may constitute violations of the Food, Drug, and Cosmetic Act or related acts.

Sandoz has announced that it has received a Complete Response Letter from the FDA for GP2013, its proposed rituximab biosimilar referencing Rituxan.