ASBM Educates St. Louis Patients, Healthcare Providers

March 24, 2016

On March 23rd, ASBM conducted an hour-long presentations entitled “Biosimilars: New Choices, New Challenges” for a group of patients and healthcare providers in St. Louis, MO.The presentation was given at a hospital complex in downtown St. Louis which includes Barnes Jewish Hospital St. Louis Children’s Hospital and Shriner’s Hospital for Children.

STL-pano-HG-small

The program began with ASBM Chairman Harry L. Gewanter, MD outlining for attendees the basic science of biologics and biosimilars, including the differences between biosimilars and chemical generics. Dr. Gewanter then provided a physician’s perspective on issues such as the need for distinguishable naming of biologics, and the need for pharmacist-physician communication in the event of a biosimilar substitution.

Schneider-STL-sm

Following Dr. Gewanter was ASBM Advisory Board Chair, University of Arizona professor of pharmacy Philip Schneider, who provided a pharmacist perspective on biosimilars. Dr. Schneider also emphasized clear product identification as critical for biologics, including biosimilars, referencing survey data showing support among pharmacists for distinct names. Dr. Schneider also examined the issue of biosimilar labeling, citing survey data that show many providers want more transparent and informative labeling than is currently required by the FDA. Finally, he outlined how many states, including Missouri, are crafting biosimilar substitution legislation that addresses the need for physician-pharmacist communication.

spiegel-stl-ppt-sm

The final presentation was from ASBM Steering Committee member Andrew Spiegel of the Global Colon Cancer Association, who provided a patient’s perspective. Mr. Spiegel expressed optimism about the new choices and lower costs biosimilars will provide. Yet he stressed the need to maintain transparency in their approval process, and to keep treatment decisions- including the decision to switch- the purview of physician and patient rather than a third party.


ASBM Educates St. Louis Patients, Healthcare Providers

March 24, 2016

On March 23rd, ASBM conducted an hour-long presentations entitled “Biosimilars: New Choices, New Challenges” for a group of patients and healthcare providers in St. Louis, MO.The presentation was given at a hospital complex in downtown St. Louis which includes Barnes Jewish Hospital St. Louis Children’s Hospital and Shriner’s Hospital for Children.

STL-pano-HG-small

The program began with ASBM Chairman Harry L. Gewanter, MD outlining for attendees the basic science of biologics and biosimilars, including the differences between biosimilars and chemical generics. Dr. Gewanter then provided a physician’s perspective on issues such as the need for distinguishable naming of biologics, and the need for pharmacist-physician communication in the event of a biosimilar substitution.

Schneider-STL-sm

Following Dr. Gewanter was ASBM Advisory Board Chair, University of Arizona professor of pharmacy Philip Schneider, who provided a pharmacist perspective on biosimilars. Dr. Schneider also emphasized clear product identification as critical for biologics, including biosimilars, referencing survey data showing support among pharmacists for distinct names. Dr. Schneider also examined the issue of biosimilar labeling, citing survey data that show many providers want more transparent and informative labeling than is currently required by the FDA. Finally, he outlined how many states, including Missouri, are crafting biosimilar substitution legislation that addresses the need for physician-pharmacist communication.

spiegel-stl-ppt-sm

The final presentation was from ASBM Steering Committee member Andrew Spiegel of the Global Colon Cancer Association, who provided a patient’s perspective. Mr. Spiegel expressed optimism about the new choices and lower costs biosimilars will provide. Yet he stressed the need to maintain transparency in their approval process, and to keep treatment decisions- including the decision to switch- the purview of physician and patient rather than a third party.


ASBM Submits Comments on Health Canada SEB Guidance

February 16, 2016

On February 15th, ASBM submitted comments to Health Canada on its December 7th Guidance on Subsequent Entry Biologics (the Canadian equivalent of biosimilars), for which Health Canada has sought comment from stakeholders.   

The Guidance calls for more labeling transparency than is currently required by the FDA. For example, the SEB sponsor must include data they generate on the product’s label and must provide safety data for all indications.

The Guidance Document and information on submitting feedback may be found here.


ASBM Submits Comments on Health Canada SEB Guidance

February 16, 2016

On February 15th, ASBM submitted comments to Health Canada on its December 7th Guidance on Subsequent Entry Biologics (the Canadian equivalent of biosimilars), for which Health Canada has sought comment from stakeholders.   

The Guidance calls for more labeling transparency than is currently required by the FDA. For example, the SEB sponsor must include data they generate on the product’s label and must provide safety data for all indications.

The Guidance Document and information on submitting feedback may be found here.


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.


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


logo logo logo