May 9, 2014
In a letter to FDA Commissioner Margaret Hamburg dated April 24, U.S. Rep. Anna Eshoo (D-CA) requested an update on FDA’s timeline for releasing guidance on biosimilar naming and interchangeability.
To read letter, click here.
May 8, 2014
On April 2nd, ASBM met with Illinois legislators in Springfield to urge them to support a biosimilar substitution bill for Illinois.
ASBM Chairman Richard Dolinar, MD gave an educational presentation to legislators entitled “Biologics and Biosimilars: Building Informed Policy at State Level” as part of the Discovering Cures Forum. The event served as a briefing for state legislators to educate them on biosimilars and will include representatives from Biotechnology Industry Organization (BIO) and Arthritis Foundation – Heartland Region.
Dr. Dolinar’s presentation emphasized the unique nature of biologics including their differences from chemical drugs, and offered physician perspectives on biosimilar substitution. Citing ASBM’s 2012 survey of 376 physicians who prescribe biologics, Dolinar noted that 88% of physicians felt it “very important or critical” to be notified of any biologic substitution.
Discovering Cures Illinois believes that sound policy in Illinois outlining parameters for safe substitution of interchangeable biologics is the best option to ensure patients have access to high-quality, safe and effective biologic medicines. Discovering Cures core concerns are to ensure transparency and the primacy of the physician-patient relationship, recognizing that treating physicians and their patients are in the best position to determine appropriate therapies.
May 8, 2014
The Alliance for Safe Biologic Medicines and other ASBM patient groups continue to write the Delaware House of Representatives requesting passage of Senate Substitute 1 for SB 118 regarding biosimilar products. A vote in the full House is expected Tuesday, May 13.
Letters to House of Representatives requesting final passage.
View AARDA letter here.
View ASBM letter here.
View GHLF letter here.
View RetireSafe letter here.
Letters to Delaware House Health and Human Development Committee:
View ASBM letter here.
View GHLF letter here.
View AARDA letter here.
View RetireSafe letter here.
April 23, 2014
ASBM Executive Director, Michael Reilly joined Kimberly Greco of Amgen and Christopher Mikson, MD of Jones Day for a biologics panel at the Food and Drug Law Institute’s (FDLI) 57th Annual Conference on April 23rd in Washington, DC. The panel was moderated by John Manthei, partner, Latham & Watkins, who also gave a brief overview of the FDA’s progress implementing the Biosimilars Price Competition and Innovation Act (BPCIA).
The panel discussed the differences between chemically-based drugs and biologics, and how these differences impact interchangeability and pharmacy substitution laws in the U.S. and E.U.
To view Mr. Reilly’s presentation for the FDLI conference, click here.
April 23, 2014
ASBM Executive Director, Michael Reilly joined Kimberly Greco of Amgen and Christopher Mikson, MD of Jones Day for a biologics panel at the Food and Drug Law Institute’s (FDLI) 57th Annual Conference on April 23rd in Washington, DC. The panel was moderated by John Manthei, partner, Latham & Watkins, who also gave a brief overview of the FDA’s progress implementing the Biosimilars Price Competition and Innovation Act (BPCIA).
The panel discussed the differences between chemically-based drugs and biologics, and how these differences impact interchangeability and pharmacy substitution laws in the U.S. and E.U.
To view Mr. Reilly’s presentation for the FDLI conference, click here.
April 8, 2014
Geneva — ASBM was invited to share its perspectives before the World Health Organization’s 58th International Nonproprietary Names Consultation for Pharmaceutical Substances, Open Session for Stakeholders. At the meeting, ASBM Chairman Richard Dolinar, M.D., shared the results of a recent ASBM survey of European Physicians that concludes using the same INN for different biologic medicines can be misinterpreted by doctors and thus have unintended consequences for patients.
To see ASBM presentation, click here.
April 8, 2014
Geneva — ASBM was invited to share its perspectives before the World Health Organization’s 58th International Nonproprietary Names Consultation for Pharmaceutical Substances, Open Session for Stakeholders. At the meeting, ASBM Chairman Richard Dolinar, M.D., shared the results of a recent ASBM survey of European Physicians that concludes using the same INN for different biologic medicines can be misinterpreted by doctors and thus have unintended consequences for patients.
To see ASBM presentation, click here.
April 2, 2014
ASBM member Global Healthy Living Foundation (GHLF), recently produced an educational video highlighting the need and importance of unique names for biosimilars.
The video includes perspectives from Steve Marmaras of GHLF; Donna Cryer a prominent patient advocate who uses biologics; former FDA official Peter Pitts; as well as ASBM executive director Michael Reilly and RetireSafe president Thair Phillips.
March 31, 2014
On March 18th in Brussels, the Alliance for Safe Biologic Medicines (ASBM) released the results of a survey of 470 European physicians from five countries regarding their prescribing habits and knowledge of biosimilar medicines. Participants in the survey included specialists in the fields of nephrology, rheumatology, dermatology, neurology, endocrinology and oncology. The results were released at a stakeholder roundtable hosted by EuropaBIO, with representatives from physician and patient groups, as well as industry and regulatory bodies.
Key findings showed:
The findings stressed that using the same INN for two medicines (both the innovator biologic and biosimilar) can be misleading. In addition to implying identical structure (53% of respondents incorrectly thought this to be the case) using the same INN for both medicines may result in false attribution of adverse events if only the INN is reported (as was the case with 17% of physicians surveyed).
The survey was released in advance of the upcoming WHO INN Consultation in Geneva where ASBM will present its findings.
Michael Reilly, executive director, of the ASBM commented: “The ASBM survey is the first large-scale survey on biosimilars in Europe. It reflects the daily clinical practice with regards to biological medicines including biosimilars, and provides facts and figures that put current international, EU as well as national policy developments in the field of naming and substitution into perspective.” – Biosimilar News, March 19th
Nathalie Moll, secretary general of EuropaBIO added, “The results of the survey indicate that the understanding of biosimilars is not yet wide-spread among physicians. At the same time, doctors need to be fully aware of the characteristics of biologics and biosimilars to be in a position to prescribe the medicine that will maximize patient outcomes.” – ThePharmaLetter, March 19th
To view the ASBM survey and presentations, click here.
To view media coverage, check Bloomberg, FirstWord Pharma, BioWorld, PanEuropean Networks, EurActiv and Generics Bulletin.
ASBM chairman Richard Dolinar, MD will appear before the World Health Organization (WHO) at its 58th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances meeting to be held April 8th.
The WHO has been considering creating a system of unique names and since the meeting in October has made progress toward compromise amongst the different positions on the naming of biosimilars. Currently, the WHO is contemplating assigning ‘biologic qualifiers’ — a short string of random letters added to the name of a biosimilar — which would allow physicians and pharmacists to distinguish biosimilars from the reference biologic.
ASBM member Global Healthy Living Foundation (GHLF), recently produced an educational video highlighting the need and importance of unique names for biosimilars. The video includes perspectives from Steve Marmaras of GHLF, Donna Cryer a prominent patient advocate who uses biologics, former FDA official Peter Pitts, as well as ASBM executive director Michael Reilly and RetireSafe president Thair Phillips.
The two-minute video will be hosted on GHLF’s website, healthybiologics.org, and will be circulated through social media.
To view video, click here.
On March 25th, Governor Mike Pence signed legislation to ensure the safe substitution of interchangeable biologic medicines, approved by the U.S. Food and Drug Administration (FDA).
Senate Bill 262 amends Indiana pharmacy regulations for the treatment of biosimilars by ensuring the proper communication between the pharmacist and the prescribing physician takes place. Specifically the new law provides that the physician must indicate if a substitution is allowable and the pharmacist must notify the treating physician within 10 days of the exact biologic product dispensed by name and manufacturer. The pharmacist is required to retain a written record of the biosimilar substitution for a period of no less than two years. In addition, the pharmacist must also make sure the patient is aware of substitutions that occur.
“This law ensures there are procedures in place to facilitate the exchange of information when biologic medicines are dispensed, while also expanding patient access to biologic medicines,” stated Dr. Dolinar.
ASBM will continue to work with state legislatures in advocating for the necessary substitution guidelines needed to ensure patient safety.
To view ASBM press release, click here.
Chairman Dr. Richard Dolinar will be part of the Discovering Cures Illinois panel on April 2nd in Springfield. The event will serve as a briefing for state legislators to educate them on biosimilars and will include representatives from Biotechnology Industry Organization (BIO) and Arthritis Foundation – Heartland Region.
Discovering Cures Illinois believes that sound policy in Illinois outlining parameters for safe substitution of interchangeable biologics is the best option to ensure patients have access to high-quality, safe and effective biologic medicines. Discovering Cures core concerns are to ensure transparency and the primacy of the physician-patient relationship, recognizing that treating physicians and their patients are in the best position to determine appropriate therapies.
The Food and Drug Law Institute (FDLI) will host their 57th Annual Conference on April 23rd and 24th in Washington, DC.
Breakout session “Interchangeability & Pharmacy Substitution Laws and Regulations in the United States and European Union” will cover compliance and liability issues related to biosimilars. The panel, moderated by John Manthei of Latham & Watkins LLP, will include Michael Reilly of ASBM, Kimberly Greco of Amgen and Christopher Mikson, MD of Jones Day.
For more information on the FDLI conference, click here.
April 7th-8th: Biosimilars and Biobetters USA, Iselin, NJ
May 12th: Interfarma, Brazil
June 15th-19th: DIA 50th Annual Meeting, San Diego Convention Center, CA
March 25, 2014
Arlington, VA – Today, the Alliance for Safe Biologic Medicines (ASBM) applauds Governor Mike Pence of Indiana in signing legislation to ensure the safe substitution of interchangeable biologic medicines, approved by the Food and Drug Administration (FDA).
“We commend Indiana in taking the lead to make patient safety the priority as life-altering biologics become more readily available to patients in the United States,” commented Richard Dolinar, M.D. Chairman of ASBM.
Senate Bill 262 amends Indiana pharmacy regulations for the treatment of biosimilars by maintaining the proper communication between pharmacists and prescribing physicians. Specifically, the new law provides that pharmacist must notify the treating physician within 10 days of the exact biologic product by manufacturer in order to attribute any adverse events that may occur. In addition, the pharmacist is required to retain a written record of the biosimilar substitution for a period of no less than two years. The pharmacists must also make sure the patient is aware of substitutions that occur.
“As a practicing endocrinologist, when it comes to treating patients, I need to know what medicines my patients are taking to properly manage disease,” continued Dolinar. “Without proper communication, I may not be able to address setbacks in treatment or accurately attribute adverse events and may lose valuable treatment time. This law ensures there are procedures in place to facilitate that exchange of information when biologic medicines are dispensed, while also expanding patient access to biologic medicines.”
Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Unlike drugs derived from chemicals, biologics are manufactured using a unique process with living cells and for this reason no two biologics made from different cell lines are ever identical. When attempting to replicate biologics, their “copies,” known as biosimilars, are similar to, but not exact versions of the biologic they aim to replicate and are often mistakenly referred to as “generics.” Even the smallest difference in the structure of a biologic medicine and its attempted copy can have a significant impact on a patient.
ASBM has supported the FDA in its mission to safely bring biosimilars to the U.S. and will continue to work with state legislatures in advocating for the necessary substitution guidelines needed to ensure patient safety remains the priority.
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