The Center for Biosimilars Staff

This week, James Stevenson, PharmD, FASHP, professor at the University of Michigan College of Pharmacy, delivered a webinar via the Academy of Managed Care Pharmacy.

Samsung Bioepis is reportedly undertaking shorter clinical trials in order to gain faster biosimilar approvals as the company seeks to compete with rival developers and to realize its first annual profits.

The Center for Biosimilars recaps the top 5 stories in biosimilar news for the week of July 3, 2017.

A recent study, published in Transfusion, analyzed 3 granulocyte-colony-stimulating factor treatments in an attempt to compare the mobilization efficiency of 2 innovator G-CSF treatments with that of 1 biosimilar treatment.

In the wake of Coherus’ 30% reduction in workforce last week—a move that followed the company’s complete response letter from the FDA regarding its CHS-1701, a pegfilgrastim biosimilar candidate—the California-based biosimilar developer has sustained yet another blow to its business.

Pegaspargase (marketed as Oncaspar), a biologic drug approved by the FDA in 2006 for acute lymphoblastic leukemia (ALL) as a component of multi-agent chemotherapy, has long gone unchallenged by biosimilar candidates. That could soon change, according to information recently reported by the Generics and Biosimilars Initiative (GaBI).

Just 2 weeks after Coherus BioSciences announced that it had received a complete response letter (CRL) from the FDA in response to its biologics license application for a pegfilgrastim biosimilar candidate, the company has laid off 51 employees, or approximately 30% of its workforce, in a bid to cut its operating costs by $10 million.

As of July, 2017, 33 US states and Puetro Rico have enacted laws concerning biosimilar substitution.

The Center for Biosimilars recaps the top 5 stories in biosimilar news for the week of June 26, 2017.

Celltrion and Teva announced today that the FDA has accepted the companies’ Biologics License Application (BLA) for CT-P10, a proposed rituximab biosimilar. FDA regulatory action is expected in early 2018.

Today, Sanofi and Regeneron announced that the European Commission has granted marketing authorization for the companies’ sarilumab (Kevzara), which is approved to treat severely active rheumatoid arthritis, and which outperformed Humira in a phase 3 trial.

Earlier this month, Biocad obtained a marketing authorization for its rituximab biosimilar in Bolivia and Honduras. The product, USMAL, will be available to patients within months. Yet the Russian firm sees roadblocks ahead for US market entry.

The Biologics Prescribers Collaborative released its comment letter to the FDA on the agency’s Considerations in Demonstrating Interchangeability, and made 5 key requests.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has delivered a positive opinion Biogen’s adalimumab biosimilar, SB5 (also known as Imraldi), referencing Humira.

The Senate today revealed its long-anticipated healthcare reform bill, The Better Care Reconciliation Act of 2017. Like the House bill, the Senate legislation leaves some features of the ACA intact, including the BPCIA.

Worldwide prescription drug sales could reach $1.06 trillion by 2022, according to a new report. This earning represents only a 6.5% compound annual growth rate, and biosimilars may well play a significant role in curbed growth.

Amgen announced Monday that the FDA has accepted its supplemental Biologics License Application for denosumab.

A viewpoint published in JAMA explains why biosimilar drugs approved in the United States for the treatment of chronic diseases may not result in expected cost savings.

A new survey of 47 healthcare C-suite executives found that drug spending has increased among healthcare leaders. That trend, the report’s authors say, will only increase in the coming years, and health system leaders will need strategies to cope with the burden.

On Wednesday, Boehringer Ingelheim announced results from a phase 3 trial of its adalimumab biosimilar candidate, BI 695501. The study’s results showed that BI 695501 and AbbVie’s branded adalimumab, Humira, have similar clinical efficacy, safety, and immunogenicity in patients with moderate to severe rheumatoid arthritis.

Last week, Amgen and Allergan announced that the FDA will review data supporting the firms' Biologics License Application for ABP 215, a bevacizumab (Avastin) biosimilar candidate.

In a big win for Sandoz, the US Supreme Court ruled today that a manufacturer of a biosimilar product can provide a notice of commercial marketing either before or after FDA approval of the drug to the reference product developer.

A recent QuintilesIMS report shows that biosimilars have led to reductions in the price of biologics in Europe. Our infographic shows 4 key takeaways from the study.View the infographic or read more about the report here.

Today, the European Medicines Agency (EMA) released its June 2017 list of medicines currently under evaluation, and many of the biosimilars are also under consideration by the FDA.