UK Health Professionals Are Well Informed About Biosimilars
July 6th 2017A survey and drug utilization analysis conducted among UK healthcare professionals found that 75% of respondents were aware that biosimilars were available on their local formularies, and 77% considered biosimilars to be either extremely or very important to save costs for the National Health Service.
New Data Show Safe Switching From Reference Infliximab to CT-P13 in IBD
July 5th 2017To date, only limited data have been available concerning long-term clinical outcomes of switching patients with inflammatory bowel disease (IBD) from reference infliximab (Remicade) to a biosimilar treatment. A new study concludes that a switch to CT-P13 from reference infliximab was both safe and feasible.
Daiichi Sankyo Parts Ways With Troubled Coherus on CHS-0214
July 5th 2017In 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.
Several Hopefuls in Early Stages of Pegaspargase Biosimilar Development
July 4th 2017Pegaspargase (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).
Study Shows CT-P6 Has Equivalent Efficacy to Reference Trastuzumab for HER2-Positive Breast Cancer
July 3rd 2017CT-P6, a proposed biosimilar of trastuzumab, showed equivalent efficacy to reference trastuzumab (Herceptin) as a neoadjuvant treatment in human epidermal growth factor receptor 2-positive (HER2-positive) early breast cancer, according to a recent phase 3 equivalence trial.
Coherus Terminates 30% of Its Workforce After FDA's Complete Response Letter
July 3rd 2017Just 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.
Physicians Express Concerns About Biosimilar Interchangeability to FDA
June 30th 2017The 52 comments the FDA received during the public commentary period on the agency’s January 2017 draft guidance, Considerations in Demonstrating Interchangeability With a Reference Product, included statements from physicians concerned about the proposed policy.
NICE Approves Baricitinib After Maker Prices for Competition With Biologics, Biosimilars
June 30th 2017The United Kingdom's National Institute for Health and Care Excellence (NICE), which provides value guidance to the National Health Service, has published its final appraisal determination for baricitinib (Olumiant), a Janus kinase inhibitor, recommending use of the drug as an option for treating severe active rheumatoid arthritis.
Review Suggests Interchangeability Nearing for Single Switch Between Infliximab and Its Biosimilar
June 30th 2017Available data from comparative clinical trials and observational studies strongly confirm the equivalence between CT-P13 and originator infliximab for the treatment of rheumatologic diseases.
The Supreme Court's Sandoz v Amgen Ruling Raises as Many Questions as It Resolves
June 29th 2017On June 28, Elaine Blais and Willy Jay, partners at Goodwin Proctor LLP, held a webinar discussing the Supreme Court’s Decision in the case of Sandoz v Amgen. While the court provided some much-needed clarity surrounding requirements of the Biologics Price Competition and Innovation Act “patent dance,” as Blais and Jay pointed out, the court’s ruling left a number of important questions unresolved.
Some See Potential of Inter Partes Review to Clear the Way for Biosimilars
June 29th 2017Even as the industry awaited news of the Supreme Court’s ruling in the case of Sandoz v Amgen, many legal experts at the 8th Annual Summit on Biosimilars earlier this month were focused on inter partes review as an alternative to patent litigation under the contentious Biologics Price Competition and Innovation Act.
The Importance of Tracking State Biosimilar Substitution Laws Across the US
June 28th 2017State lawmakers are pushing legislation to advance automatic biosimilar substitution at a rapid pace across the nation—33 states and Puerto Rico have already taken action, and 8 more states have bills pending, according to Stephanie Hoops, a market analyst at Decision Resources Group.
Kevzara Earns European Approval, Puts Further Pressure on Humira
June 27th 2017Today, 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.
Sandoz Gains European Approval for Erelzi as US Legal Woes Continue
June 27th 2017Sandoz announced today that is has received approval from the European Commission for its biosimilar etanercept (which will be marketed as Erelzi) for the treatment of multiple inflammatory diseases, including rheumatoid arthritis, axial spondyloarthritis, psoriasis, and psoriatic arthritis.
Could the United States Invoke the Bayh-Dole Act to Curb Drug Prices?
June 27th 2017As patients, policy makers, and providers alike wait to learn the fate of the contentious new Senate healthcare bill, some stakeholders suggest that existing legislation—dating back to the 1980s—could potentially play a role in driving down prescription drug costs.
Biosimilars Present an Opportunity for Oncology Patients, Prescribers, and Health Systems
June 26th 2017Biologic medications are an integral, crucial, and effective part of medical management for many life-threatening diseases and conditions, including cancer. As a recent position paper by the European Society for Medical Oncology (ESMO) points out, the anticancer market is expected to pass the €140 billion (apx. $157 billion) by 2020.
Biocad's Rituximab Biosimilar Enters Latin America; Roadblocks Remain in the US
June 26th 2017Earlier 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.