News

Targeting sustained and stringently defined clinical remission in patients with moderately active rheumatoid arthritis (RA) receiving full-dose combination therapy with etanercept plus methotrexate before considering dose or regimen changes may help improve the likelihood that patients will remain in clinical remission 1 year after the changes are made.

The Brazilian Society of Clinical Oncology has released its official position on the use of biosimilars in oncology. Thus far, only 2 oncology biosimilars (filgrastim and trastuzumab) have been approved for use in Brazil, though the number of applications filed with the National Health Surveillance Agency is expected to grow steadily in the coming years.

The FDA and Commissioner Scott Gottlieb, MD, have made a number of announcements already in 2018. Here are 3 key regulatory developments that have taken place in the early days of January.

Drug maker Alteogen has announced that it will file an Investigational New Drug (IND) application with the FDA for its proposed biosimilar aflibercept (ALT-L9), an anti–vascular endothelial growth factor therapy referencing Regeneron’s Eylea, during 2018.

Japanese drug makers Kissei Pharmaceutical Company and JCR Pharmaceuticals have announced positive results of a phase 3 study for JR-131, a proposed biosimilar to darbepoetin alfa (Aranesp).

Four hospital groups, representing approximately 450 US hospitals, are planning to create their own nonprofit generic drug company in a bold move designed to address generic drug shortages and high prices affecting their hospitals.

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.