Posts – Page 47 – Safe Biologics

FDA Advisory Panel Recommends Approval of Biosimilar Infliximab

February 10, 2016

On February 9th, the FDA’s Arthritis Advisory Committee held a hearing on CT-P13, a biosimilar to infliximab marketed internationally as Remsima or Inflectra.

Infliximab is approved to treat conditions including Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Psoriasis (Pso), Crohn’s Disease (CD) and Ulcerative Colitis (UC). This would be the first biosimilar for a monoclonal antibody (MAb) approved by the FDA.

ASBM Chairman Harry Gewanter MD noted that many physician and patient groups have raised concerns about approving CT-P13 for IBD indications (CD and UC) based on data from RA and AS, due to different mechanisms of action.

For these reasons, Health Canada did not approve CT-P13 for UC and CD. Nevertheless, the AAC voted 21-3 to approve CT-P13 for all indications of its reference product.

Any indications for which FDA approval was based on extrapolation should be clearly identified on a biosimilar’s label, Dr. Gewanter cautioned, so that physicians can make informed decisions and can have confidence in biosimilars.

Dr. Gewanter’s remarks may be read here , and ASBM’s written testimony read here.

House Energy & Commerce Committee Holds Hearing on Biosimilars

February 5, 2016

On February 4, the House Energy and Commerce Health Subcommittee held a hearing to discuss implementation of the Biologics Price Competition and Innovation Act (BPCIA).

Sean Cavanaugh, Deputy Administrator and Director of the Center for Medicare at the Centers for Medicare and Medicaid Services (CMS), and Janet Woodcock, the Director of the Center for Drug Evaluation and Research at the Food and Drug Administration (FDA), offered testimony at this hearing.

Members of the committee expressed frustration over the FDA’s delay in releasing guidances on interchangeability, naming, labeling, and extrapolation. Dr. Woodcock said that the FDA should be issuing draft guidances on interchangeability, naming, and labeling this year. She noted that the agency will continue to review and approve biosimilar applications regardless of whether or not the guidances have been issued.

Committee members were concerned that CMS’ biosimilar reimbursement policy would stifle innovation. ASBM has previously expressed concern with this rule; read ASBM’s comment letter here.

ASBM Participates in Brussels Labelling Workshop

February 3, 2016

On February 2nd, ASBM’s Chairman Harry Gewanter and its Executive Director Michael Reilly participated in a panel discussion in Brussels, Belgium. The panel was held as part of a Labelling Workshop hosted by the European Biopharmaceutical Enterprises (EBE) and EuropaBio.

Dr. Gewanter and Mr. Reilly discussed the findings of ASBM’s surveys of U.S. physicians and pharmacists, which show a desire for more informative, accurate labeling of biosimilars. In particular, providers want greater transparency regarding indication extrapolation and the source of data appearing on the label than is currently required by the U.S. FDA.

Mr. Reilly praised Health Canada’s recent SEB (biosimilar) Guidance, which requires a biosimilar’s label to show data generated by its sponsor, and provide safety data for all approved indications.

ASBM Submits Comments Supporting Biosimilars User Fee Act (BsUFA) Reauthorization

January 20, 2016

On January 19th, ASBM submitted comments to the FDA supportive of reauthorizing the Biosimilars User Fee Act (BsUFA) which funds the FDA’s biosimilar program through fees paid by biosimilar sponsors:

“ASBM supports reauthorization of BsUFA because the FDA must always have adequate funding and resources to bring these medicines to patients both safely and in a timely manner. Continuing the BsUFA funding mechanism…will ensure FDA has the resources it needs.”

The FDA had held a hearing on BsUFA December 18th, at which ASBM Steering Committee Member Andy Spiegel, Director of the Global Colon Cancer Association, testified in support of the program.

The comment letter ASBM submitted may be read in full here.

Video: The Evolution of Biotechnology- The Arrival of Biosimilars

December 14, 2015

This short video, produced by Policy Matters Canada, explains some of the differences between biologic medicines and traditional chemical drugs, how biosimilars differ from generics, and how these differences create policy challenges for regulators and lawmakers.

https://www.youtube.com/watch?v=J2jQpSRX0F0

Video: The Evolution of Biotechnology- The Arrival of Biosimilars

December 14, 2015

This short video, produced by Policy Matters Canada, explains some of the differences between biologic medicines and traditional chemical drugs, how biosimilars differ from generics, and how these differences create policy challenges for regulators and lawmakers.

https://www.youtube.com/watch?v=J2jQpSRX0F0

ASBM Presents to Ontario Hospital Association

December 9, 2015

On December 9th in Toronto, ON, ASBM Executive Director Michael Reilly gave a presentation entitled “Biosimilars: On the Forefront of Medical Innovation” as part of a webinar hosted by the Ontario Hospital Association (OHA). The OHA is a leader on the issue of patient safety in Canada and represents 151 hospitals.

Prior to the presentation, a short, informative video was shown, providing an overview of the differences between biologics and chemical drugs. The video addressed some of the unique challenges biosimilars create for policymakers and regulators, with an emphasis on the value of distinguishable names and accurate tracking of adverse events.

Mr. Reilly’s presentation focused on how regulators can address these challenges in order to build physician confidence in biosimilars: by supporting distinguishable naming, good communication with pharmacists during substitution, and transparency in product labeling. Physician perspectives from ASBM surveys in eleven countries were presented, including its survey of 400 Canadian prescribers. The presentation may be viewed here.

Health Canada Releases New SEB/Biosimilar Guidance

December 8, 2015

On December 7th, Health Canada released a revised draft of Guidance on Subsequent Entry Biologics (the Canadian equivalent of biosimilars) for stakeholder consultation. The obective of the Guidance, entitled “Information and Submission Requirements for Subsequent Entry Biologics (SEB Guidance)“, is to provide sponsors with guidance to satisfy the information and regulatory requirements under the Canadian Food and Drugs Act and Regulations for the authorization of SEBs in Canada.

The Guidance Document and information on submitting feedback may be found here. Comments will be accepted until February 15th.

Health Canada Releases New SEB/Biosimilar Guidance

December 8, 2015

On December 7th, Health Canada released a revised draft of Guidance on Subsequent Entry Biologics (the Canadian equivalent of biosimilars) for stakeholder consultation. The obective of the Guidance, entitled “Information and Submission Requirements for Subsequent Entry Biologics (SEB Guidance)“, is to provide sponsors with guidance to satisfy the information and regulatory requirements under the Canadian Food and Drugs Act and Regulations for the authorization of SEBs in Canada.

The Guidance Document and information on submitting feedback may be found here. Comments will be accepted until February 15th.

EMA Accepts Application for Second Biosimilar for Enbrel

December 8, 2015

On December 8th, the European Medicines Agency (EMA) accepted a Marketing Authorization Application (MAA) for the second biosimilar to the EU-licensed Enbrel (etanercept), a tumor necrosis factor alpha (TNFα) inhibitor. The biosimilar is seeking approvals for all indications of its reference product, which is used to treat autoimmune conditions such as rheumatoid arthritis and psoriasis. More information can be found here. The EMA Committee for Medicinal Products had recommended approval for the first biosimilar to Enbrel, Benepali, on November 20th.