News

This month saw steps forward for biosimilars in the rheumatology space, with product approvals in multiple markets and the publication of long-term data that support the use of biosimilar agents in treating inflammatory diseases.

Sandoz has announced that it has entered into a partnership with Taiwan-based biotechnology manufacturing and development company EirGenix, Inc, for a proposed trastuzumab biosimilar referencing Herceptin.

Amgen has now answered Coherus BioSciences’ complaint and denies that it has infringed on Coherus’ patents. Amgen also said that the patents are invalid for failure to comply with requirements of the law.

“The path forward requires a sustainable, fair payment system in which drug prices reflect the value provided and reward innovations that improve outcomes,” wrote Robert M. Califf, MD, and Andy Slavitt.

Last Friday, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Juta Pharma’s pegfilgrastim biosimilar, Grasustek.

A recent exploratory study found signs that retail pharmacies may be associated with higher nonadherence to rheumatoid arthritis (RA) medications.

This week, dermatology experts are gathering in Paris, France, for the 6th Congress of Skin Inflammation and Psoriasis International Network to discuss advances in the treatment of inflammatory skin diseases. During the congress, researchers from the University of Verona in Verona, Italy, will report findings from a study in which patients were switched between 2 different biosimilar infliximab products during treatment of chronic plaque psoriasis.

The Center for Biosimilars® recaps the top news for the week of April 22, 2019.

The FDA has approved Samsung Bioepis’ etanercept biosimilar, SB4, as Eticovo (etanercept-ykro). A representative from Samsung Bioepis has confirmed approval of the product to The Center for Biosimilars® in an email. The biosimilar is already approved in a variety of other markets under the name Benepali.

Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, has reported the results of a clinical study of its proposed bevacizumab biosimilar, BAT1706, referencing Avastin.

During the first quarter of 2019, Samsung Bioepis’ biosimilars revenue increased to $175 million, up from $128 million in the first quarter of 2018. Those numbers, say Biogen, are driven by the launch of biosimilar adalimumab, Imraldi.

The approval comes as welcome news for AbbVie, which seeks to strengthen its immunology sales as it faces biosimilar competition for its flagship therapy, adalimumab (Humira).

Earlier this month, pharmacy benefit managers (PBMs) were called before the Senate Finance Committee to answer questions about how their businesses impact drug prices for Americans. While the executives deflected criticism and pointed to issues like legal challenges to biosimilars as playing a key role in keeping drug prices high, lawmakers and officials are taking steps to rein in PBMs.

New data from a subset analysis of MONITOR‐GCSF, a multicenter study from Europe, show that biosimilar filgrastim has similar effectiveness and safety to reference filgrastim (Neupogen).

Access to therapy for ulcerative colitis (UC) and Crohn disease (CD) may not be consistent with treatment guidelines because of payer policies that do not concur with the American Gastroenterological Association clinical pathways for the treatment of inflammatory bowel disease.

Xbrane Biopharma, a Swedish biotechnology company, says it is starting its phase 3 trial of its ranibizumab biosimilar, referencing Lucentis, and also set sales targets for the treatment for patients with wet age-related macular degeneration.

Myelodysplastic syndromes, which are a diverse group of neoplasms that arise from hematopoietic stem cells, are characterized by ineffective hematopoiesis, leading to cytopenias such as anemia and neutropenia.

In terms of attitudes toward the safety and efficacy of biosimilars, 84% of survey respondents agreed that switching to a biosimilar is safe and effective for patients whose conditions are treated by reference products, but only 54% agreed with the extrapolation of indications.

Adalimumab and infliximab showed the highest discontinuation rate due to patient remission, followed by golimumab, in the study of patients with rheumatoid arthritis (RA).

National guidelines and reimbursement rules are likely to be key drivers of disparities; in some countries, biologics are not reimbursed at all, while in others, patients may need to have high disease activity levels, or may need to fail numerous small-molecule drugs before gaining access to biologics. Differences in cost-effectiveness thresholds used in Health Technology Assessments may also be a factor.

In Johannesburg, South Africa, the World Health Organization (WHO) recently arranged for closed meetings between government representatives, nongovernmental organizations, academics, experts, and the pharmaceutical industry to address concerns regarding fair pricing and patient access to pharmaceuticals, particularly related to middle- and low-income countries. The second Fair Pricing Forum took place from April 11-13, 2019.

As biosimilars begin to gain ground in the country, Janssen, maker of a number of brand-name biologic products that face current or oncoming biosimilar competition, has launched a program—the Biologics Savings Partnership—that it says will offer patients brand-name biologics at prices similar to those of biosimilar options.

After treatment withdrawal, 58.3% of patients with ankylosing spondylitis (AS) had relapsed. Half of the relapses appeared within 6 months.

This week, the FDA granted priority review to Novartis’ innovator biologic, RTH258, brolucizumab. The vascular endothelial growth factor (VEGF) inhibitor is intended to treat wet age-related macular degeneration.

CMS’ final 2020 Payment Notice will allow insurers to stop counting the value of manufacturer drug coupons for branded drugs towards a beneficiary’s maximum out-of-pocket costs in order to promote the use of generic drugs.

The authors write that these data add to the totality of the evidence supporting the biosimilarity of the biosimilar infliximab with its reference.

The Center for Biosimilars® recaps the top news for the week of April 15, 2019.

Fuji Pharma will market Alvotech’s biosimilar ustekinumab in Japan, the companies announced this month.

This month, US magistrate judge Richard A. Lloret granted Boehringer Ingelheim (BI)’s motion to compel AbbVie to produce prelitigation disclosures and settlements concerning its brand-name adalimumab, Humira.

Yesterday, the European Parliament approved a proposal to allow waivers of supplementary protection certificates (SPCs) for EU generics and biosimilars by a vote of 572 to 36.