GaBI: Physicians’ views on biosimilars labelling

April 20, 2015

On 23 March 2015, the Alliance for Safe Biologic Medicines (ASBM), which represents patients and physicians, as well as originator biological and biosimilars companies in the US, released results of a survey, which showed that physicians ‘support transparent, clear labels with data that enables prescribers to learn about and evaluate the medicines available to their patients’ [1].

The survey, which was carried out prior to the first biosimilar approval, questioned 400 US physicians about what they expected and wanted to see when it comes to biosimilars labelling. Specialists in dermatology, endocrinology, oncology, nephrology, neurology and rheumatology were included in the research, which was carried out via a web-based survey.

Read the full article here.

ASBM Presents at 60th WHO Naming Meeting

April 14, 2015

Geneva, Switzerland – The Alliance for Safe Biologic Medicines (ASBM) Chairman Harry Gewanter, M.D. and International Advisory Board Chair and pharmacist, Philip J. Schneider, M.S., F.A.S.H.P., jointly presented at the World Health Organization’s (WHO) 60th International Nonproprietary Naming Stakeholders Session on Monday, April 13, 2015. The duo provided perspectives from both a physician and pharmacist viewpoint and offered support for the WHO’s Biological Qualifier (BQ) proposal.

This stakeholder session was the second time Dr. Gewanter was given the privilege to present and it was ASBM’s fourth time attending. ASBM was especially pleased that Dr. Schneider presented with Dr. Gewanter and was able to provide a pharmacist’s view on the topic of naming.

“We are so grateful for the opportunity to present at the WHO,” said Dr. Gewanter in his opening remarks. “Biosimilars’ high sensitivity to manufacturing differences, light, heat, denaturing; and their potential to stimulate unwanted immune reactions, means clear product identification is essential. ASBM believes that information, cooperation, communication and collaboration are vital to ensuring the best outcomes for patients across the globe. Implementing the WHO’s BQ proposal will make patient safety a priority.”
Dr. Schneider agreed that the BQ proposal would help ensure safety through clear product identification.

“All medicines, regardless of their similarity, should be easily identifiable,” said Dr. Schneider. “The pharmacy community has long advocated that drug names be clear to help avoid confusion and errors – and this could not be more true when it comes to highly complex biologic medicines. They must be easily distinguishable from each other and from other medicines. It is our hope that regulators around the world, including the FDA and EMA, adopt the BQ proposal by the WHO INN Programme, and its application within their jurisdictions.”

ASBM has been very supportive of the WHO’s draft BQ proposal that would assign a four-letter alphabetic code to all biologics. In September of last year, ASBM and 14 of its member groups submitted comments to the WHO supporting the BQ proposal because it ensures clear product identification and promotes manufacturer accountability.

About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.

For more information, please contact:

Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326
Email: Michael@safebiologics.org

Podcast on FDA Biosimilar Approval

April 12, 2015

Nigel Rulewski, MD, Vice President of Global Strategic Drug Development and Head of Quintiles Global Biosimilars Unit, discusses the historic step the U.S. Food and Drug Administration (FDA) took on March 6, 2015 approving the first ever biosimilar product for the U.S. market.

Listen to the podcast here.

March 2015 Newsletter

April 7, 2015

Labeling Survey Released as FDA Makes First Approval 

 

On March 23, ASBM Executive Director Michael Reilly, presented at “The State of Autoimmune Disease: a National Summit” held at the National Press Club and hosted by the American Autoimmune Related Diseases Association. During his presentation, he released the findings from ASBM’s new biosimilar labeling survey that reveals that physicians who prescribe biologics support transparent, clear labels with data that enables prescribers to learn about and evaluate the medicines available to their patients.

 

Read more on the survey here.

 

ASBM to Participate in WHO Naming Meeting

 

On April 13, ASBM Chairman Dr. Harry Gewanter and Advisory Board Chair Dr. Philip Schneider, will participate in the World Health Organization’s (WHO) 60th International Consultation on Nonproprietary Names in Geneva. Dr. Gewanter and Dr. Schneider will attend the INN meeting to offer support for the WHO’s Biological Qualifier (BQ) proposal. 

 

CE Class on Biosimilars for Pharmacists

On March 15, ASBM held a five-hour continuing education (CE) class offered through the Long Island University (LIU Pharmacy) to educate pharmacists on biosimilars. The class,”The Fundamentals of Biosimilars: What Every Pharmacist Will Need to Know,” was held at the New York LaGuardia Airport Marriott and explained what biologics and biosimilars are, how they are manufactured and regulatory challenges associated with them.

The class discussed the basic science and manufacturing of biologic medicines; the clinical implications of the key features of biologics size, complexity, sensitivity/propensity for change that distinguish biologic medicines from chemical drugs; their difference from generic drugs for purposes of patient care, pharmacovigilance, and pharmacy practice; and the important regulatory and policy considerations – that many state capitals are currently legislating across the country. Over 150 pharmacists attended the class and ASBM plans to host more classes like this throughout the country over the coming months.

Read more on the class here.

 

 

ASBM Presents Canadian Survey Results in BIOTECanada Webinar 

 

On March 31, Executive Director Michael Reilly, participated in a webinar hosted by BIOTECanada to share the results of the Canadian Physician Survey on SEBs. The webinar briefed patient group representatives on the results of the survey and discussed common misconceptions about SEBs, in addition to the need for a distinguishable naming scheme for all biologics, including SEBs.

 

View the presentation here. 

 

 

In the States

 

California

The Senate Business, Professions and Economic Development Committee will hold a hearing on April 13 at 1:00pm on SB 671.

 

Colorado

On April 6, Governor John Hickenlooper signed SB 71 into law. 

 

Georgia
SB 51 and HB 195 have been introduced in Georgia with communication language and hearings are expected to be held soon.

 

Maryland

Biosimilar bills are pending in Annapolis with only one week before the legislature adjourns. The House Committee on Health and Government Operations held a hearing on April 2 on SB 537.

 

North Carolina

The Senate took up the version of SB 197 that had been passed by the House last week. The bill passed the 1st reading in the Senate, and was referred to Senate Committee on Rules and Operations.

 

Tennessee

The House and Senate rescheduled when the bill would come to the floor in each chamber last week. SB 984 was on the Senate Calendar for April 6 and passed the Senate as amended, and HB 572 is on the House Calendar for April 8. 

 

Texas

Letters of support are needed in Austin for SB 542 and HB 751 that require communication with prescriber within a “reasonable time” after dispensing.

 

Utah

Governor Gary Herbert signed HB 279 into law last week.

 

Washington

The House referred SB 5935 to the Appropriations Committee.

 

Upcoming Conferences:

  • April 13-15: WHO 60th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland
  • April 20-21: 2015 FDLI Annual Conference in Washington, DC 
  • April 23-24: 13th EGA- European Biosimilars Group Conference in London, England
  • May 27-28: World Biosimilar Congress USA in San Diego, CA
  • June 14-18: DIA 2015 51st Annual Meeting in Washington, DC

The Pew Charitable Trusts: More States Demand Notification to Use Biosimilar Drugs

April 5, 2015

Without the medicine Rachelle Crow takes for her rheumatoid arthritis, the 29-year-old Michigan woman’s face would frequently feel as if it were engulfed in flames. She would barely be able to crawl out of bed. She would have trouble opening or closing her fists or lifting her 3-year-old daughter.

Crow can do all those things thanks to Cimzia, one of a highly complex, usually expensive class of drugs known as biologics that derive from living organisms. Cimzia is recommended for women, like Crow, who are trying to get pregnant.

Read full article here.

The Pew Charitable Trusts: More States Demand Notification to Use Biosimilar Drugs

April 5, 2015

Without the medicine Rachelle Crow takes for her rheumatoid arthritis, the 29-year-old Michigan woman’s face would frequently feel as if it were engulfed in flames. She would barely be able to crawl out of bed. She would have trouble opening or closing her fists or lifting her 3-year-old daughter.

Crow can do all those things thanks to Cimzia, one of a highly complex, usually expensive class of drugs known as biologics that derive from living organisms. Cimzia is recommended for women, like Crow, who are trying to get pregnant.

Read full article here.

State Lawmakers Weigh Issue Of ‘Biosimilars’ — New, Life-Saving Drugs

March 26, 2015

DENVER (CBS4) – Much cheaper, life-saving drugs could become available this year. They are called biosimilars and are copycat versions of drugs for diseases like rheumatoid arthritis, breast cancer and psoriasis.
A bill before Colorado lawmakers would let pharmacists substitute the biosimilars for brand name drugs. The medications are different from the generics that have been on the market.
View the story here .

Biosimilars bill approved by Colorado Legislature

March 26, 2015

Colorado’s biosimilars bill letting pharmacists provide patients with generic drugs in place of name-brand biotech medicines now needs only a governor’s signature to become law.
The state House of Representatives passed the bill with only one ‘no’ vote on Tuesday, and it heads on to John Hickenlooper desk.
 
Read more here.

Biosimilars bill approved by Colorado Legislature

March 26, 2015

Colorado’s biosimilars bill letting pharmacists provide patients with generic drugs in place of name-brand biotech medicines now needs only a governor’s signature to become law.
The state House of Representatives passed the bill with only one ‘no’ vote on Tuesday, and it heads on to John Hickenlooper desk.
 
Read more here.

New ASBM Survey Provides Physicians’ Views on Biosimilar Labeling

March 23, 2015

Timely survey released as FDA approves first biosimilar

The Alliance for Safe Biologic Medicines today released the results from a survey on physicians’ priorities related to biosimilar labeling. ASBM first shared the key survey findings at the “The State of Autoimmune Disease: a National Summit” held at the National Press Club and hosted by the American Autoimmune Related Diseases Association. The survey reveals that physicians who prescribe biologics support transparent, clear labels with data that enables prescribers to learn about and evaluate the medicines available to their patients.

A strong consensus was apparent among the four hundred physicians surveyed, all of whom are board-certified, practice in the U.S. and prescribe biologic medicines. They include dermatologists, endocrinologists, oncologists, nephrologists, neurologists and rheumatologists. ASBM Executive Director Michael Reilly presented at the autoimmune summit and discussed the role biotech medicines play in treating autoimmune diseases. His presentation addressed the recent approval of the first biosimilar medicine in the U.S. and the timeliness of the new survey data as FDA considers the multiple biosimilar applications said to be pending before the agency.

“ASBM commends the FDA for their work to make biosimilars a reality for patients across the country,” said Reilly. “We believe this data provides FDA with clear guideposts for what is necessary to foster physician confidence in biosimilar medicines. The survey was conducted prior to the first biosimilar approval and is more consistent with the draft guidance released in 2012 than the label of the first biosimilar product.”

In the survey, participants were asked to rank the importance to the following questions on a five- point scale, with five being the highest:

  • How important is it that a product label for a biosimilar clearly indicates that it is a biosimilar? 90% of respondents rate the importance as a 4 or 5.
  • How important is it that the biosimilar label includes the analytical data developed by the biosimilar sponsor to demonstrate its analytical similarity to the reference product? 82% rate the importance as a 4 or a 5.
  • How important is it that the biosimilar label includes the clinical data, if any, submitted to FDA by the biosimilar sponsor to demonstrate that it is highly similar to the reference product? 83% rate the importance as a 4 or 5.
  • How important is it that the label explicitly states that specific indications or conditions of use that are approved for the originator product are NOT approved for the biosimilar product? 79% rate the importance as a 4 or 5.

ASBM has conducted surveys on physicians’ understanding of and views about biologics and biosimilars in the U.S., in Europe and in Canada, with the goal of providing to regulators the information needed to help advance the success and safe use of biologic medicines around the world.

View the survey here.

View the one pager here.

About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.

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