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This week, US Magistrate Judge Richard Lloret directed Boehringer Ingelheim to disclose its launch plans for its biosimilar adalimumab, Cyltezo, as part of a long-running patent dispute with AbbVie, maker of the reference adalimumab, Humira.

This month, biosimilar developer Sandoz filed suit against Amgen, asking the United States district court for the Northern District of California for a declaratory judgment of patent noninfringement and invalidity.

A recent issue brief, published by the Commonwealth Fund, described Germany’s approach as an alternative to the current US model that imposes high cost-sharing on patients.

Advanced therapy medicinal products (ATMPs), including gene therapies, cell therapies, and tissue engineering products, are providing groundbreaking approaches to treating rare diseases. However, the costs associated with these drugs are expected to pose challenges for affordability and the sustainability. A newly published paper looked ahead to the potential for—and challenges related to—biosimilars of ATMPs.

The Center for Biosimilars® recaps the top news for the week of February 18, 2019.

More payers began to significantly adjust their reimbursement strategies for biosimilars last year, according to pharmacy benefit manager (PBM) Magellan Rx Management.

In an interview with The Center for Biosimilars®, Mona Chitre, PharmD, CGP, chief pharmacy officer and vice president of clinical operations and health innovation at Excellus Blue Cross Blue Shield, said increased spending on specialty pharmacy products is a primary reason for health plans’ growing interest in developing strategies to address biosimilars.

AbbVie has announced that the FDA has accepted for priority review its New Drug Application for upadacitinib for the treatment of rheumatoid arthritis (RA). Upadacitinib is a proposed once-daily, small-molecule, oral Janus kinase inhibitor that, if approved, could be an alternative to therapy with such injectable biologics as AbbVie’s flagship RA treatment, adalimumab (Humira), which will face biosimilar competition in the United States by 2023.

Biosimilar developer Sandoz today announced the launch of its biosimilar adalimumab, Hyrimoz, in Spain. The biosimilar, referencing Humira, was authorized for sale in the European Union in July 2018.

A United States District Judge in New Jersey has allowed a proposed class-action lawsuit against 3 major insulin makers to proceed.

The comment period has recently closed for the FDA’s proposed approach to the transition of insulins and other products that have historically been regulated as drugs and follow-ons to regulation as biologics and biosimilars, and among the comments from stakeholders is a suggestion that one drug maker may be interested in selling biosimilars of its own products.

After the Association for Accessible Medicines’ (AAM’s) Access! 2019 annual meeting came to a close last week, The Center for Biosimilars® spoke with Christine Simmon, senior vice president of policy and strategic alliances, AAM, and executive director, AAM’s Biosimilars Council, to get her take on some of the outcomes of the meeting.

The United Kingdom’s National Institute for Health and Care Excellence (NICE) today released a final appraisal of pertuzumab (Perjeta) together with intravenous trastuzumab and chemotherapy for the treatment of HER2-positive early breast cancer, and recommended pertuzumab for use in patients if they have lymph node–positive disease and if drug maker Roche adheres to its promised discount for the drug.

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.