News

Biosimilar developer Samsung Bioepis, a partnership between Samsung BioLogics and Biogen, has announced a new licensing agreement with the private equity firm C-Bridge Capital that will allow the drug maker to expand its reach into mainland China.

A recent study examining Medicare Part D reimbursement policies for off-label uses, using dermatology as a focus, found that health coverage decisions have significant shortcomings that could hamper patient access to evidence-based treatments.

The FDA recently released final guidance on the use of therapeutic proteins in developing biologics and biosimilars. "Immunogenicity Testing of Therapeutic Protein Products—Developing and Validating Assays for Anti-Drug Antibody Detection" represents current FDA thinking about developing and validating assays for anti-drug antibody (ADA) detection.

This week, the United States Court of Appeals for the Federal Circuit found that Momenta lacked standing to appeal a decision upholding a patent covering abatacept (Orencia) and said that Momenta’s appeal was rendered moot by the drug makers’ choice to stop developing its biosimilar.

GP2013, a biosimilar rituximab developed by Sandoz and licensed in the European Union under the brand names Rixathon and Riximyo, is used to treat both malignant and inflammatory diseases. A recently published paper, appearing in Arthritis Care and Research, says that researchers detected no safety risks when switching patients with rheumatoid arthritis from reference rituximab (Rituxan) to the biosimilar.

The Center for Biosimilars® recaps the top news for the week of February 4, 2019.

Express Scripts said this week that it expects US drug spending to rise about 2% over the next 3 years, lower than projected inflation rates. However, a lack of competition will affect 2 of the costliest categories of pharmaceuticals—inflammatory conditions and diabetes—between 2019 and 2021.

This week, Senator Patrick Leahy, D-Vermont, reintroduced The Creating and Restoring Equal Access To Equivalent Samples (CREATES) Act.

New research, published in BioDrugs, underscores the long-term efficacy and safety of treating rheumatoid arthritis (RA) with biosimilar rituximab, CT-P10.

Some stakeholders have welcomed the proposed rule to bar drug makers from giving pharmacy benefit managers rebates, while others raised serious concerns.

One emerging method to monitor potential differences is to apply aptamers: single-stranded DNA or RNA oligonucleotides. Aptamers can bind to various targets, and because they have a defined fold that can recognize a target with high affinity, they can be used as surrogate antibodies.

Mundipharma announced today that it has launched Pelmeg, a biosimilar pegfilgrastim referencing Neulasta, in Germany, the Netherlands, and Ireland.

Results from the phase 3 REFLECTIONS B327-02 study in patients with HER2-positive metastatic breast cancer (MBC) were first presented in abstract form, but have now been reported in detail.

In a newly published correspondence, Italian rheumatology providers called into question whether recently published results from the DANBIO registry can be used to guide non-medical switching from reference etanercept (Enbrel) to biosimilar SB4 (Benpali) in patients with inflammatory diseases.

The assumption that Medicare Part B payment rates lead providers to create higher drug utilization for costlier treatments in order to benefit from larger add-on payments is not correct, a recent white paper said. The paper from Xcenda, a part of AmerisourceBergen, also found similar results when looking at physician-administered drugs in the hospital outpatient setting.

On Friday, Fresenius Kabi announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for its MSB11022, a biosimilar adalimumab referencing Humira. The CHMP issued its opinions for the marketing of 2 brand names of the drug: Idacio and Kromeya.

A recent white paper recaps the many barriers to biosimilar adoption in the United States and proposes a few ways that plans could change their reimbursement policies to help boost uptake.

A raft of biosimilars possibly coming to market is not expected to relieve the burden of healthcare costs in 2019, but it is possible that the combination of products in the queue, as well as reimbursement changes, could be the beginning of change, according to a drug pricing forecast out this week from Vizient.

On Thursday, HHS proposed a rule intended to reduce patients’ out-of-pocket costs for prescription drugs by blocking rebates and discounts given to pharmacy benefit managers, Part D plans, and Medicaid managed care organizations and encouraging discounts given directly to patients.

The Center for Biosimilars® recaps the top news for the week of January 28, 2019.

Finnish-based biosimilar developer, Paras Biopharmaceuticals Finland Oy, said this week that it is ready to begin testing its potential romiplostim biosimilar in clinical trials.

While the body of reassuring data on the safety and efficacy of biosimilars continues to grow, worrisome information about stakeholders’ levels of awareness of these products is also coming to light, and January 2019 saw the publication of a spate of studies showing low levels of patient and provider education on biosimilars.

Innovent Biologics, a China-based biopharmaceutical company, recently submitted a New Drug Application for its proposed bevacizumab biosimilar, IBI-305, referencing Avastin, to the Chinese regulatory agency, the National Medical Products Administration.

By 2023, the segment of the biologics market in the United States that faces competition from biosimilars will have grown 3 times larger than in 2019, resulting in nearly 10% cumulative savings, says IQVIA.

The House Committee on Oversight and Reform held its first hearing into drug prices this week and received testimony that pointed to increased biosimilar competition as a part of the solution to the problem.

A specific focus of the European Commission and European Parliament is to investigate the effect potential mergers and acquisitions (M&As) will have on the state of the market.

While a majority of survey respondents said that they were at least somewhat familiar with current developments in oncology biosimilars, analyses of open-ended definitions found that only 1 participant could fully define a biosimilar, according to researchers.

Biosimilar adalimumab is making its way to patients, some of whom have expressed concerns about the presence of citrate in some of the available biosimilars.

In the past year, Biocon received marketing approvals in the European Union for both its biosimilar pegfilgrastim (sold as Fulphila) and its biosimilar trastuzumab (sold as Ogivri), which were co-developed in a partnership with Mylan.

In observational studies of patients who have switched treatment from a reference biologic to a biosimilar, some higher rates of discontinuation have been observed when these studies are compared with blinded switching studies.