News

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of January 15, 2018.

Amgen and Allergan announced on Thursday that the European Commission has granted a marketing authorization to Mvasi, a biosimilar bevacizumab referencing Avastin, for the treatment of certain cancers.

Antagonism of tumor necrosis factor-alpha (TNF-alpha) may be a good treatment strategy to counter the deleterious effects of TNF-alpha on the development of insulin resistance and the pathogenesis of type 2 diabetes.

On January 11, Celltrion and its partner Teva filed 2 new lawsuits against Genentech in a California district court.

An editorial, recently published in Annals of the Rheumatic Diseases, discussed the results of a study that found that an adalimumab (Humira) concentration-based tapering strategy was not inferior to the conservative strategy, conducted over 26 weeks.

Biosimilar developer Sandoz announced today that it has entered into a global partnership with India-based Biocon to develop, manufacture, and commercialize multiple biosimilars targeting immunology and oncology indications.

In an expert review, the authors provide transparency about biosimilar production, approvals, risk, and benefits to help improve confidence that the same safety and efficacy can be expected from biologics and their biosimilars.

A newly published retrospective study found that patients who received a combination therapy with infliximab and azathioprine early on had significantly increased linear growth compared to patients whose therapy was stepped up.

Yesterday, Novartis released new data from its head-to-head CLARITY study that shows that its secukinumab (Cosentyx) was significantly more effective than ustekinumab (Stelara) in the treatment of psoriasis in delivering clear or almost clear skin at 12 and 16 weeks.

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) announced yesterday that it will not make any sudden changes to the nation’s regulatory framework following the country’s exit from the European Union.

FDA Commissioner Scott Gottlieb, MD, delivered the keynote address during a symposium, "Transparency at the US Food and Drug Administration,” hosted today by the Johns Hopkins Bloomberg School of Public Health. In his speech, Gottlieb announced a number of new initiatives to make the reasoning behind FDAs decision-making more transparent to all healthcare stakeholders.

Three European nations are amending their policies in order to create better conditions for biosimilar uptake and the cost savings that biosimilars provide to health systems.

Researchers based in the Republic of Korea have published data suggesting that they were able to produce a promising biosimilar obinutuzumab candidate from the plant Nicotiana benthamiana L. that is equivalent to obinutuzumab produced in glyco-engineered Chinese hamster ovary cells.

Sandoz, a division of Novartis, announced today that the FDA has accepted its Biologics License Application (BLA) for a proposed adalimumab biosimilar (referencing AbbVie’s Humira).

A recent research letter, published in the British Journal of Dermatology, reports that a biosimilar of etanercept, SB4 (approved as Benepali in the European Union and Brenzys in The Republic of Korea, Canada, and Australia), is associated with fewer injection-site reactions and less immunogenicity than reference etanercept (Enbrel), while maintaining equivalent efficacy.

MedPAC called for changes to Medicare Part D to remove the financial disincentives that block the use of lower-cost biosimilar therapies.

Rituximab is approved for use in hematological malignancies and in rheumatoid arthritis (RA), but is also used off-label in the treatment of antibody-dependent auto-immunological diseases. In off-label indications, alternative dosing schedules are sometimes used, though no dose-finding trials are available to help guide dosing in such diseases.

At this week’s 36th Annual J.P. Morgan Healthcare Conference, numerous biosimilar developers and reference product sponsors outlined their plans for the future. Our infographic provide 9 key takeaways.

Innovator drug developer Genentech, maker of the biologic therapies Avastin (bevacizumab) and Rituxan (rituximab), faces challenges from biosimilar developers in the United States and abroad. This week saw developments in cases concerning both molecules in US and Japanese courts of law.

Patients with rheumatoid arthritis (RA) who require a change in therapy from anti–tumor necrosis factor inhibitor (anti-TNF) treatments to biologics with a different mechanism of action (MOA) had higher treatment persistence and lower healthcare costs than patients who cycled anti-TNF drugs, resulting in lower healthcare costs per persistent patient among the MOA switchers, a recent study finds.

At the J.P. Morgan Healthcare Conference that took place this week in San Francisco, California, Republic of Korea-based biotech company Celltrion announced that it is preparing to build a new overseas production plant that will add to the strength of its biosimilar program.

On Thursday, the FDA announced that it is taking new steps in 2018 to make the development and approval of biosimilars more efficient.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of January 8, 2018.

At the J.P. Morgan Healthcare conference, Lupin Pharmaceuticals, a subsidiary of India-based Lupin Limited, announced biosimilar development plans for the company.

A review recently published in Lung Cancer: Targets and Therapy describes patient selection for treatment with bevacizumab, and argues that bevacizumab has a good safety profile in patient subpopulations previously considered ineligible for treatment with the therapy.

FDA Commissioner Scott Gottlieb, MD, has said that he is open to rethinking the aspects of a 35-year-old law that create incentives for drug companies to develop orphan drugs for rare diseases affecting fewer than 200,000 people, because the market has changed since the law was passed.

On the third day of the 36th Annual J.P. Morgan Healthcare Conference, Samsung Biologics, which forms Samsung Bioepis together with its partner Biogen, explained that its success is driven by short development timelines for its biosimilar products. Meanwhile, AbbVie, maker of the blockbuster Humira, featured its arsenal of products that could help insulate the drug developer from biosimilar adalimumab competition.

In an editorial that was recently published in Alimentary Pharmacology and Therapeutics, authors D. Sawbridge, MD, and S. Subramanian, MD, discussed how to mitigate primary nonresponse to infliximab.

Rituximab (Rituxan) is more effective and has lower rates of discontinuation than other disease-modifying treatments in newly diagnosed patients with relapsing-remitting multiple sclerosis, according to a Swedish study published online in the January 8, 2018, issue of JAMA Neurology.

During the second day of the 36th Annual J.P. Morgan Healthcare Conference, Amgen and Mylan highlighted their progress with biosimilar therapies, while Roche and Sanofi focused on progress with innovator products and combinations that may help insulate them from biosimilar and follow-on competition.