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The Center for Biosimilars® recaps the top news for the week of February 11, 2019.

As brand-name biologics that have achieved strong sales begin to age, and as biosimilar developers grow closer to gaining approval for and launching their products, innovator biologic developers are taking on new strategies to defend their profits and market share.

An American Medical Association survey of 1000 physicians regarding the impact of prior authorization (PA) found that most providers reported a significant or negative impact on patient care, and more than a quarter reported a serious adverse event.

Recent research attempted to assess consumer response to the disclosure of drugs' list prices in direct-to-consumer advertising.

During the Association for Accessible Medicines’ Access! 2019 meeting, Doug Long, vice president of industry relations at IQVIA, gave an update about what trends are being identified in the generic and biosimilars markets across the globe.

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.

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.

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

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

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.

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.

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.

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.

Coherus BioSciences announced on Friday that it has become the latest biosimilar developer to settle with AbbVie, maker of the brand-name adalimumab, Humira, over a proposed biosimilar. In an intellectual property twist, Coherus also announced that it has sued a rival biosimilar developer, Amgen.

Bio-Thera Solutions, a China-based biosimilar developer, announced that it has dosed the first patients in its phase 3 clinical study of BAT1806, a proposed biosimilar tocilizumab referencing Actemra, an interleukin-6 inhibitor.

The Center for Biosimilars® recaps the top news for the week of January 21, 2019.

A new report from research institution NORC at the University of Chicago finds that hospitals and health systems face high annual growth in drug spending, and some of the highest-spend drugs are those facing biosimilar challenges.

Drug makers often point to substantial research and development (R&D) costs as reasons for the high prices of innovator drugs, particularly in oncology. However, some stakeholders have expressed skepticism about whether R&D costs are indeed in line with the prices that drug makers charge. In a new study published in JAMA, investigators sought to compare sales of cancer drugs with estimated R&D costs.

A South Korean court ruled this week that penalties imposed against Samsung BioLogics, parent company of biosimilar developer Samsung Bioepis, by the Financial Services Commission (FSC) for allegedly committing fraud have been suspended.

Amgen and Allergan today announced positive topline results of a combined phase 1 and phase 3 study evaluating ABP 798, a proposed biosimilar rituximab, in comparison with the reference Rituxan in patients with rheumatoid arthritis.

Despite the challenges inherent in biosimilars, they have a fairly high probability of success, said Edric Engert, managing director of Abraxeolus Consulting, in a presentation at the 14th Biosimilars Summit, held January 22-23, 2019, in Alexandria, Virginia.

Drug maker Alvotech announced this week that it has raised $300 million, through a private bond offering, that it will used to continue its growth, refinance debt, and further develop its biosimilar pipeline.

Last week, CMS unveiled new, voluntary changes for Medicare Part D. The new 5-year model, which CMS calls Part D Payment Modernization, will test the feasibility of shifting more risk to Medicare Advantage and Part D plans.