May 14th 2024
The ISPOR report highlights the urgent need for clear guidance on when and how to conduct health technology assessments (HTAs) for biosimilars, emphasizing the challenges faced by HTA agencies and the evolving role of HTAs in evaluating biosimilar value.
CEA White Paper Calls for "Easy and Inexpensive" Guidance on Interchangeable Biosimilars
February 12th 2018On Friday, the White House’s Council of Economic Advisors (CEA), an agency within the Executive Office of the President, released a white paper titled “Reforming Biopharmaceutical Pricing at Home and Abroad.”
Budget Bill Contains Wins for Biosimilars, Effort to Reduce Drug Costs Continues
February 9th 2018With a new budget bill having been signed by President Trump, the second government shutdown of 2018 is now over. The Bipartisan Budget Act of 2018 contains several provisions of interest to biosimilars stakeholders.
ACR Backs Biosimilars in New White Paper
February 8th 2018The American College of Rheumatology (ACR)'s previous position on biosimilars was one of caution during the initial development, evaluation, and approval of these drugs, but, writes the organization, “Now that biosimilars have been used successfully in Europe, with rigorously acquired data supporting their broader use, and as the [United States] is on the verge of a similar transition, the ACR is poised to reconsider its position.”
Another Province Adds Biosimilar Etanercept to Formulary as Canadian Drug Prices Fall
February 8th 2018Recently, the pan-Canadian Pharmaceutical Alliance (pCPA) annonced that it has reached a deal with generic drug makers to cut the prices of dozens of popular medications in exchange for an agreement that no jurisdiction will move to a system of public tendering for its drugs. In addition to the nationwide generic price cut, the province of Quebec also announced that it is the most recent Canadian area to add biosimilar etanercept (Erelzi) to its formulary.
Renewed Push for CREATES Act as Budget Deadline Looms
February 5th 2018Former Representative Henry Waxman told The Center for Biosimilars® in an email that the CREATES Act “…tackles one of the numerous problems driving high drug prices—drug manufacturers’ use of anti-competitive tactics to block access to generic drugs.
Angus Worthing, MD, Says ACR Will Continue to Push HHS On Part B Reimbursement
February 3rd 2018In an interview with The Center for Biosimilars®, Angus Worthing, MD, FACP, FACR, chair of the American College of Rheumatology (ACR) Government Affairs Committee, explained the next steps for ACR after submitting a comment letter to HHS on reimbursement for Part B drug costs and prior authorizations.
Advocacy Group Calls for Congressional Oversight Hearings on Biosimilars
February 2nd 2018Patients for Biologics Safety and Access, a coalition of patient advocacy organizations, called on the US Senate Committee on Health, Education, Labor and Pensions and the House Committee on Energy and Commerce to convene oversight hearings on biosimilar medicines.
ACR Urges HHS to Reform Policies on Part B, Prior Authorizations
February 1st 2018The American College of Rheumatology (ACR), which represents over 9500 rheumatologists and rheumatology health professionals, recently submitted a letter to HHS in response to the department’s request for information on Promoting Healthcare Choice and Competition Across the United States.
Trump Says Drug Prices to "Come Rocketing Down" With Azar Helming HHS
January 30th 2018Trump said of Azar, who was confirmed by a vote of 55 to 43 on January 24 to replace Tom Price, MD, as Secretary of HHS, “He’s going to get those prescription drug prices way down…it’s going to come rocketing down.”
Biosimilars Council Backs Pfizer With Amicus Brief in Ongoing Infliximab Case
January 30th 2018On January 26, the Biosimilars Council (a division of the Association for Accessible Medicines) filed an amicus brief opposing Johnson & Johnson’s motion to dismiss a complaint brought by Pfizer over its biosimilar infliximab, Inflectra, which references Johnson & Johnson’s innovator product, Remicade.
Drug Costs, Healthcare Spending Grow Over Time for Medicaid Expansion Populations
January 27th 2018Healthcare spending for the Medicaid expansion population increased steadily over time for beneficiaries who remained enrolled in Medicaid, according to a new analysis from Avalere Health. The analysis also found that spending for prescription drugs increased over the study period, with pharmacy costs (excluding prescription drug claims for hepatitis C treatments) almost doubling over the 2.5-year time period during which the cohort was tracked
EMA to Survey Pharma on Brexit Preparedness
January 24th 2018The European Medicines Agency (EMA) has launched a survey of pharmaceutical companies to assess their preparedness for the United Kingdom’s upcoming withdrawal from the European Union, as it hopes to identify any concerns about the continued supply of drugs during the Brexit transition.
Report Points to Pricing, Litigation, and Lack of Interchangeability as Threats to Biosimilars
January 24th 2018The report from Trinity Partners details findings from qualitative research with 10 medical directors at US payer organizations, representing plans covering over 100 million commercial and Medicare enrollees in the United States.
Brazilian Society of Clinical Oncology Issues Position on Biosimilars
January 22nd 2018The 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.
UK Regulator Seeks to Reassure Pharma as Brexit Nears
January 17th 2018The 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.
Genentech Defends Patents on Bevacizumab, Rituximab in US, Japanese Courts
January 13th 2018Innovator 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.