News

Insurers operating in the Affordable Care Act marketplace face fresh uncertainties as they plan for 2018: whether Congress will continue in its efforts to repeal or replace the ACA, whether the Trump administration will enforce the individual mandate, or even whether the federal government will continue to pay insurers for cost-sharing reductions are all unanswered questions.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of August 7, 2017.

The US Court of Appeals for the Federal Circuit today dismissed Amgen’s appeal of a previous district court ruling that denied its motion to compel discovery from Hospira in a Biologics Price Competition and Innovation Act (BPCIA) litigation.

A recently published study demonstrates that sarilumab improves patient-reported outcomes in patients with rheumatoid arthritis who did not achieve adequate response with, or who were intolerant to, anti-tumor necrosis factor (anti-TNF) agents.

A recent international, randomized, double-blind study comparing the proposed biosimilar GP2013with both the reference rituximab approved in the European Union and in the United States found that GP2013 demonstrated 3-way pharmacokinetic and pharmacodynamic equivalence with both products in patients with rheumatoid arthritis.

FDA Commissioner, Scott Gottlieb, MD, has created a new FDA working group of senior agency staff who will investigate ways to increase generic drug competition.

The US Supreme Court’s recent ruling in the case of Sandoz v Amgen led to industry speculation that biosimilar applicants could lack incentive to participate in the information exchange process with reference product sponsors, or the so-called “patent dance,” provided for under the Biologics Price Competition and Innovation Act (BPCIA).

Coherus BioSciences announced this week that it has filed a petition for inter partes review of a key patent protecting Amgen’s etanercept (Enbrel). Patent 8,163,522 (also known as the ‘522 patent) concerns a process for isolating non-soluble proteins.

Kyle F. Skiermont, PharmD, COO of Fairview Pharmacy Services, spoke with The Center for Biosimilars® about his experience with payers and providers as they prepare for the impact of biosimilar drugs and possible non-medical switching.

The introduction of anti-tumor necrosis factor-alpha agents has improved treatment options for patients with inflammatory bowel disease. However, these agents can also lead to increased vulnerability to infections, development of autoimmune diseases, malignancies, and decreased immunogenicity of vaccinations.

The FDA’s Office of Surveillance has released its findings from an inspection of Biocon’s troubled manufacturing facility in Bangalore, India. ​​The agency listed 10 observations made during the agency’s inspection conducted during May and June of 2017.

Contradicting standard advice given to most patients that the preferred medication is a less-expensive generic medication, rather than a brand-name drug, some health insurers are telling consumers the opposite: they must buy brand-name drugs even when cheaper generics are available.

New York-based Regeneron has announced that it will allow one of its key partnerships with the French drug maker Sanofi to terminate at the end of the year without an extension. The companies’ Antibody Discovery Agreement was responsible for the discovery and development of such drugs as alirocumab (Praluent), dupilumab (Dupixent), and sarilumab (Kevzara).

The FDA’s biosimilar pathway has encouraged a robust product pipeline, but the fact that few biosimilar drugs have been approved by the agency thus far means that there is still some industry uncertainty on the FDA’s approach to this class of products.

Many health systems, payers, and physicians have an expectation that biosimilars will result in immediate and significant cost reductions (similar to what we have seen with generic pharmaceuticals).

A recent survey of 588 Canadian patients revealed that many patients had serious concerns about biosimilar substitution.

AbbVie is engaged in new litigation over its blockbuster adalimumab (Humira). This week, the drug maker filed suit against Boehringer Ingelheim in a Delaware federal court, saying that BI will infringe on 74 of its patents for adalimumab in its development of a biosimilar product, BI 695501.

The development of biosimilars is focused on the minimization of potential differences between the proposed biosimilar and reference product, as well as the establishment of a robust manufacturing process to consistently produce a high-quality biosimilar.

The FDA’s Arthritis Advisory Committee (AAC) did not recommend the approval of Janssen Biotech’s sirukumab, a proposed monoclonal antibody for the treatment of moderate to severe rheumatoid arthritis, over concerns about mortality.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of July 31, 2017.

The Senate today passed the FDA Reauthorization Act of 2017 (FDARA) in a roll call vote.

Reimbursement remains a substantial concern in the market for biosimilar products, according to Amanda Forys, MBA, director of Xcenda’s Reimbursement Policy Insights consulting team.

A recently published study shows that Amgen’s ABP 501 (Amjevita), referenced on Humira, shows that the product has similar efficacy, safety, and immunogenicity to its reference in patients with moderate to severe rheumatoid arthritis.

Sanofi’s 2017 second-quarter sales from its diabetes and cardiovascular business declined by 15% relative to the same sales quarter last year, the French drug maker reported on Monday. Sanofi cited biosimilar competition in Europe as well as exclusion from US formularies as the chief reasons for its steep sales decline.

Coherus BioSciences has moved for a stay of discovery in BPCIA litigation concerning its proposed pegfilgrastim biosimilar, CHS-1701, referenced on Amgen’s blockbuster drug Neulasta.

Data from a recent study show that biosimilar filgrastim is readily used in France for the prophylaxis of chemotherapy-induced neutropenia. The data also demonstrate that clinicians’ assessment of febrile neutropenia risk is driven by patient factors more than by the European Organisation for the Research and Treatment of Cancer’s risk category of the chemotherapy regimen.

A recent survey shows that some patients have greater concerns about automatic substitution of biosimilar products than they do about the high cost of biologic drugs.

An examination of national policies on biosimilars in 10 European Union member states concludes that supply-side policies targeting price can limit biosimilar penetration in the long term, while demand-side policies positively impact biosimilar uptake and are important drivers for biosimilar market penetration.

Amgen and Allergan announced today that the companies have submitted a Biologics License Application for ABP 980, a proposed trastuzumab (Herceptin) biosimilar.

How will the 35% price discount by Merck/Samsung Bioepis on their infliximab biosimilar, compared with the reference, influence stakeholder uptake?