Posts – Page 37 – Safe Biologics

ASBM Meets with Canadian Health Officials in Ottawa

October 5, 2017

On October 4th, ASBM Executive Director Michael Reilly met with several Canadian health officials in Ottawa to discuss naming and substitution policy, and preview data from ASBM’s Canadian prescriber survey which will be released October 17th at the DIA Canada Annual Meeting in Ottawa.

While in Ottawa, Mr. Reilly met with the Minister of Health’s Office, the Minister of Innovation, Science, and Economic Development’s Office, the Prime Minister’s Office, the Chair of the Parliamentary Standing Committee on Health, Health Canada’s Office of Policy and International Collaboration, and its Biologics and Genetic Therapies Directorate.

ASBM Presents Poster at ESMO 2017

September 15, 2017

On September 10, 2017 ASBM presented a poster at the European Society of Medical Oncology (ESMO) 2017 Congress which presented perspectives of oncologists from 12 countries regarding biosimilar substitution. Responses were drawn from five recent ASBM surveys which gathered perspectives of more than 1,850 biologic prescribers in Australia, Canada, France, Germany, Italy, Spain, the United Kingdom, and the United States. ASBM Steering Committee Member Andrew Spiegel, head of the Global Colon Cancer Association, presented the poster at the conference.

*Andrew Spiegel, CEO of the Global Colon Cancer Association, presents the poster at the ESMO 2017 Congress.*

Among the findings:

Approximately two-thirds of respondents (63%) believe that pharmacy-level substitution is acceptable, provided that they are notified in advance.
Most respondents feel that it is important for them to have the authority to prevent pharmacist substitution, with 81% of respondents considering this authority “very important” or “critical”.
Most (83%) respondents feel that it is important that they be notified if the prescribed biologic medicine has been substituted.

View the poster here.

ASBM Supports WHO Naming Plan in Comments to Australia’s TGA

September 12, 2017

On July 28th, 2017 the Australian Therapeutic Goods Administration (TGA) announced that it was seeking comments from interested parties on the nomenclature for biologic medicines, including biosimilars. In a comment letter dated September 7th, ASBM responded, advocating for distinct naming of all biologics and biosimilars, and urging the TGA to adopt the World Health Organization’s Biological Qualifier (BQ) proposal. The BQ would assign a distinguishing suffix to biologics and biosimilars in order to aid in accurate identification and tracking.

From the comment letter:

The WHO INN Committee has been discussing approaches for global naming harmonization for several years, and ASBM has been engaged with this group since 2013. ASBM believes the WHO proposal to assign Biological Qualifier (BQ) suffixes —an alphabetic suffix assigned at random to a biological active substance manufactured at a specified site— is an easy-to-use model that can become a global standard, allowing for clear product identification, facilitating manufacturer accountability, and protecting patient safety. We were surprised that TGA did not list the adoption of the BQ for consideration as a potential naming option for biologic medicines. We encourage TGA to consider this as a naming option that will meet each of the outcomes sought, with the added benefit of enabling global naming harmonization.

ASBM met with the TGA and its parent agency the Australian Department of Health in February 2017 to share results of our survey of 160 Australian prescribers of biologic medicines. 76% of survey respondents supported TGA issuing distinct names for all biologics, including biosimilars.

Read the full comment letter here.

ASBM Supports WHO Naming Plan in Comments to Australia’s TGA

September 12, 2017

On July 28th, 2017 the Australian Therapeutic Goods Administration (TGA) announced that it was seeking comments from interested parties on the nomenclature for biologic medicines, including biosimilars. In a comment letter dated September 7th, ASBM responded, advocating for distinct naming of all biologics and biosimilars, and urging the TGA to adopt the World Health Organization’s Biological Qualifier (BQ) proposal. The BQ would assign a distinguishing suffix to biologics and biosimilars in order to aid in accurate identification and tracking.

From the comment letter:

The WHO INN Committee has been discussing approaches for global naming harmonization for several years, and ASBM has been engaged with this group since 2013. ASBM believes the WHO proposal to assign Biological Qualifier (BQ) suffixes —an alphabetic suffix assigned at random to a biological active substance manufactured at a specified site— is an easy-to-use model that can become a global standard, allowing for clear product identification, facilitating manufacturer accountability, and protecting patient safety. We were surprised that TGA did not list the adoption of the BQ for consideration as a potential naming option for biologic medicines. We encourage TGA to consider this as a naming option that will meet each of the outcomes sought, with the added benefit of enabling global naming harmonization.

ASBM met with the TGA and its parent agency the Australian Department of Health in February 2017 to share results of our survey of 160 Australian prescribers of biologic medicines. 76% of survey respondents supported TGA issuing distinct names for all biologics, including biosimilars.

Read the full comment letter here.

ASBM Shares Australian Data at BMJD Conference

September 8, 2017

At the 5^th World Congress on Controversies, Debates & Consensus in Bone, Muscle & Joint Diseases (BMJD), ASBM Steering Committee member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, recently presented, “Real World Considerations for the Use of Biosimilars in Rheumatology: What do Australian Physicians Think?” The conference took place on the Gold Coast of Australia, August 31^st through September 3^rd.

Over the past year since the ASBM Australian survey was conducted, ASBM has attended many conferences and hosted a variety of meetings to relay these specific data findings – including with members of the Australian Department of Health, Therapeutic Goods Administration (TGA) and senior health ministers in Parliament.

The 5th edition of the BMJD Congress is just one such event, which aims to facilitate healthy discussion on emerging issues, and clinical and therapeutic dilemmas in the areas of osteoarthritis, rheumatoid arthritis, in amatory arthritis, pain, and other musculoskeletal diseases. At the BMJD Conference, ASBM shared a subset of data from practicing rheumatologist, which represented a fourth of total respondents.

Survey findings are consistent with what we have seen expressed publicly from Australian Rheumatologists. In February 2016, the Australian Rheumatology Association called for a robust pharmacovigilance program to be set up in order to track safety and efficacy of the infliximab biosimilar, Inflectra. In the absence of switching studies and post-market data-collection, many prescribers are defaulting to “dispense as written” (DAW), which is believed to reflect low confidence and uptake of biosimilars in Australia.

Nearly ninety percent (89%) of Australian physicians consider it “very important” or “critical” that they are notified as to which medication is dispensed to their patient. This sentiment is shared by biologic prescribers globally.

ASBM survey data also pointed to the fact that Australian prescribers overwhelmingly (76%) support the TGA issuing distinct naming for all biologics, including biosimilars.

As regulators seek to bring the health and economic benefits of biosimilars to patients, stated Mr. Spiegel, “building physician confidence is critical to the success of these medicines.” The bottom line is prescribers of biologic — no matter what their specialty — want to see true data demonstrating that substitution can occur without loss of safety and efficacy for the protection of their patients.”

View Mr. Spiegel’s presentation here.

ASBM Welcomes Madelaine Feldman as Chair

September 7, 2017

ARLINGTON, VA- In a meeting today, the Alliance for Safe Biologic Medicines (ASBM) introduced rheumatologist Madelaine Feldman, MD, FACR as the organizations incoming chairperson. Dr. Feldman succeeds outgoing chair Harry L. Gewanter, MD, FAAP, FACR, whose 3-year term expired August 31, 2017. Dr. Feldman will be the third chairperson since ASBM was founded in 2010.

The next few years are likely to be decisive ones for many biosimilar policy questions worldwide, said Michael Reilly, executive director of ASBM. We look forward to Dr. Feldmans expertise and guidance as ASBM works to settle these questions in a way that promotes new therapeutic choices for patients without jeopardizing the safety and efficacy of their treatment.

Dr. Feldman is a practicing rheumatologist in New Orleans, LA, vice president of the Coalition of State Rheumatology Organizations (CSRO), as well as founder and past president of the Rheumatology Alliance of Louisiana.

Madelaine has a strong record of leadership in the physician and patient community, said Gewanter. Her clinical experience, systemic knowledge and history of advocating for patients and physicians will be a great asset to ASBMs work worldwide. I know she will be a great success as ASBMs incoming chair.

Reilly praised Dr. Gewanters leadership and noted that during his tenure ASBMs membership has more than doubled and the scope of its international work has grown exponentially. Today, in addition to the United States, ASBM is engaged in biosimilar policy discussions in Australia, Canada, Europe, and Latin America. We thank Dr. Gewanter for his work representing ASBM before international regulators including the WHO, and for his guidance at the federal and state level in the U.S. said Reilly.

Dr. Gewanter will continue to remain involved with ASBM, returning to the Advisory Board as immediate past chair.

The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals including patients, physicians, pharmacists, manufacturers of both innovative and biosimilar medicines and others, working together to ensure patient safety remains 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

# # #

ASBM Welcomes Madelaine Feldman as Chair

September 7, 2017

ARLINGTON, VA- In a meeting today, the Alliance for Safe Biologic Medicines (ASBM) introduced rheumatologist Madelaine Feldman, MD, FACR as the organizations incoming chairperson. Dr. Feldman succeeds outgoing chair Harry L. Gewanter, MD, FAAP, FACR, whose 3-year term expired August 31, 2017. Dr. Feldman will be the third chairperson since ASBM was founded in 2010.

The next few years are likely to be decisive ones for many biosimilar policy questions worldwide, said Michael Reilly, executive director of ASBM. We look forward to Dr. Feldmans expertise and guidance as ASBM works to settle these questions in a way that promotes new therapeutic choices for patients without jeopardizing the safety and efficacy of their treatment.

Dr. Feldman is a practicing rheumatologist in New Orleans, LA, vice president of the Coalition of State Rheumatology Organizations (CSRO), as well as founder and past president of the Rheumatology Alliance of Louisiana.

Madelaine has a strong record of leadership in the physician and patient community, said Gewanter. Her clinical experience, systemic knowledge and history of advocating for patients and physicians will be a great asset to ASBMs work worldwide. I know she will be a great success as ASBMs incoming chair.

Reilly praised Dr. Gewanters leadership and noted that during his tenure ASBMs membership has more than doubled and the scope of its international work has grown exponentially. Today, in addition to the United States, ASBM is engaged in biosimilar policy discussions in Australia, Canada, Europe, and Latin America. We thank Dr. Gewanter for his work representing ASBM before international regulators including the WHO, and for his guidance at the federal and state level in the U.S. said Reilly.

Dr. Gewanter will continue to remain involved with ASBM, returning to the Advisory Board as immediate past chair.

The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals including patients, physicians, pharmacists, manufacturers of both innovative and biosimilar medicines and others, working together to ensure patient safety remains 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

# # #

FDA Approves Sixth Biosimilar; Second for Humira

August 28, 2017

On August 25th, the US Food and Drug Administration (FDA) approved Cyzelto adalimumab-adbm (Cyltezo, Boehringer Ingelheim) for multiple indications.

Cyltezo is a biosimilar of AbbVie’s Humira (adalimumab). This is the second FDA-approved biosimilar to Humira; adalimumab-atto (Amjevita, Amgen, Inc) was the first, approved in September 2016.

Cyltezo is a tumor necrosis factor (TNF) blocker approved for the treatment of adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, and moderate-to-severe plaque psoriasis.

View the product labeling and prescribing information for Cyltezo (adalimumab-adbm) here.

FDA Approves Sixth Biosimilar; Second for Humira

August 28, 2017

On August 25th, the US Food and Drug Administration (FDA) approved Cyzelto adalimumab-adbm (Cyltezo, Boehringer Ingelheim) for multiple indications.

Cyltezo is a biosimilar of AbbVie’s Humira (adalimumab). This is the second FDA-approved biosimilar to Humira; adalimumab-atto (Amjevita, Amgen, Inc) was the first, approved in September 2016.

Cyltezo is a tumor necrosis factor (TNF) blocker approved for the treatment of adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, and moderate-to-severe plaque psoriasis.

View the product labeling and prescribing information for Cyltezo (adalimumab-adbm) here.

ASBM Presents Poster at Australian Oncologist Conference

August 8, 2017

On August 3rd in Melbourne, Australia, ASBM Steering Committee member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, presented a poster at the 2017 Annual Scientific Meeting of the Medical Oncology Group of Australia (MOGA).

Nearly 400 Australian medical oncologists gathered for this meeting, themed Real World Oncology: Translating Discovery in to Practice. View the poster here.

andy-moga — *Mr. Spiegel discusses the Australian survey findings with a conference attendee.*

Mr. Spiegel reviewed data from the ASBM’s Australian survey, ASBM’s most recent physician survey. The poster presentation specifically focused on the oncology subset which showed that 80% of respondents feel that it is either “Very Important” or “Critically Important” for them to decide which biologic is dispensed to their patient. Furthermore, most (83%) also feel that it is either “Very Important” or “Critically Important” that they be notified if the prescribed biologic medicine has been substituted.

Mr. Spiegel further explained the policy implications behind the data and how ASBM advocates in Australia and around the world to further physician’s perspectives on these issues.