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In August 2017, Sandoz, a Novartis company, announced the launch of its etanercept biosimilar (Erelzi) in Canada. In December 2017, Ontario became the most recent Canadian province to add the biosimilar etanercept to its public drug plan for the treatment of multiple inflammatory diseases.

Intravitreal injection of bevacizumab (Avastin) has revolutionized the treatment of diabetic eye disease, and has emerged as an important treatment modality, either as primary or adjuvant therapy for diabetic macular edema and proliferative diabetic retinopathy.

Novartis announced today that it is initiating the SURPASS trial, a head-to-head clinical trial of secukinumab (Cosentyx) versus a proposed biosimilar adalimumab (referencing Humira and being developed by Sandoz, a Novartis division) in patients with ankylosing spondylitis.

On the first day of the 36th Annual J.P. Morgan Healthcare Conference, biosimilar developers Coherus, Pfizer, and Teva all laid out their strategies for the year ahead.

In November 2017, the Federal Trade Commission (FTC) held a meeting, comprising industry groups representing generic and brand-name drugs, pharmacies, and pharmacy benefit managers, to discuss possible solutions to increase competition and lower the cost of drugs in the United States. Afterward, numerous stakeholders submitted comment letters to the FTC addressing competition issues.

Australian biosimilar developer NeuClone has announced that it is developing a proposed biosimilar denosumab (referenced on Amgen’s Prolia, Xgeva).

Momenta Pharmaceuticals’ M923, a proposed adalimumab (Humira) biosimilar, showed bioequivalent pharmacokinetics (PK) and similar safety and tolerability to both EU- and US-licensed Humira in healthy subjects, according to findings from a phase 1 study published today in Pharmacology Research and Perspectives.

Writing in a Perspectives article, Michele K. Dougherty, PhD, and colleagues at the FDA predict the success of the agency’s biosimilars program and anticipate that as biosimilar development programs continue to mature, there will be an influx of biosimilar approval applications filed at the agency, and that the FDA and the biopharmaceutical industry will continue to build on the lessons learned from early biosimilar development programs.

The FDA approved a record-breaking 46 novel drugs in 2017. Our latest infographic breaks down the FDA's approval history for the last decase.

Mumbai-based Glenmark Pharmaceuticals launched a biosimilar adalimumb, Adaly, in the Indian marketplace this week, following Hetero's launch of Mabura.

This week, STAT held a webinar entitled "What to Expect in Biotech 2018." The broadcast was hosted by Adam Feurstein, a senior biotech reporter, and Damian Garde, a national biotech reporter. The goal of the webinar was to provide a framework of the themes that are likely to shape the biotech sector in the coming year, as well to provide a look at biotech stocks in 2018.

While the European experience with biosimilars is one of significant uptake of biosimilars, individual European nations have had distinctly different levels of uptake. These differences are largely due to local variation in pricing and reimbursement, education levels, population characteristics, and stakeholder incentives.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of January 1, 2018.

AbbVie is increasing Humira's price by 9.7%. That price increase could add $1.2 billion to the US healthcare system’s drug costs in 2018, according to one analyst.

The FDA has released new draft guidance aimed at encouraging generic drug competition as part of its continued implementation of the Drug Competition Action Plan.

Patients with renal anemia undergoing hemodialysis who were treated for up to 24 months with the intravenous biosimilar epoetin alfa HX575 (Binocrit) showed hemoglobin outcomes equivalent to reference epoetin alfa.

On January 2, counsel for the Saint Regis Mohawk Tribe filed a motion for discovery and requested an oral hearing concerning which judges will sit on the Patent Trial and Appeal Board (PTAB) panel that oversees its case.

Momenta Pharmaceuticals and Mylan have announced that they will begin a pivotal clinical trial of their jointly developed M710, a proposed biosimilar of the anti–vascular endothelial growth factor (anti-VEGF) therapy aflibercept, referenced on Eylea.

Can lower cost biosimilars create a policy solution for seniors enrolled in the Medicare Coverage Gap Discount Program?

Today, Indian drug maker Hetero launched a biosimilar of adalimumab (referenced on Humira, made by AbbVie) to be marketed in India under the name Mabura. This is the fourth biosimilar Hetero has brought to the Indian market.

A new study used flow cytometry to compare phosphorylation levels of intracellular epitopes in peripheral blood mononuclear cells from patients with psoriasis in clinical remission who were treated with reference infliximab versus healthy controls, and further evaluated whether a switch from reference infliximab to biosimilar CT-P13 affected intracellular phosphorylation patterns.

Many drugmakers rang in the new year with increases in list prices of dozens of drugs that will take effect in 2018.

Israel-based Protalix BioTherapeutics has announced positive interim data from its phase 2 clinical trial of a proposed oral anti–tumor necrosis factor (anti-TNF) therapy, OPRX-106.

In 2017, the FDA more than doubled the number of drugs it approved compared with the previous year, with 46 novel medicines receiving the FDA’s endorsement in 2017.

A phase 3 trial of SB5, a proposed biosimilar to adalimumab (AbbVie’s Humira), showed that SB5 was equivalent to its reference with respect to the American College of Rheumatology's 20% improvement criteria (ACR20).

A newly published study evaluating LG Chem's proposed biosimilar etanercept in comparison with its reference (Enbrel) found that LBEC0101 had equivalent clinical efficacy and a comparable safety profile to the reference etanercept, and that the proposed biosimilar was well tolerated.

Republic of Korea–based drug developer Polus has sold $9.37 million in convertible bonds to its affiliate Amnis.

The Psoriasis Stratification to Optimize Relevant Therapy (PSORT) study assessed real-world levels of self-reported non-adherence to traditional systemic and biologic therapies used for psoriasis, and evaluated psychological and biomedical factors associated with non-adherence using multivariable analyses.

Mylan and Biocon ended 2017 with more positive news for their biosimilar program; on December 29, 2017, the partnership announced that Brazil’s National Sanitary Surveillance Agency (ANVISA) had approved their trastuzumab biosimilar.

Bevacizumab is employed cautiously in patients with multifocal glioblastomas rather than single glioblastomas because of a fear, based on unconfirmed preclinical data, that bevacizumab can increase the invasive tumor phenotype.