ASBM Urges Illinois Legislators to Support Biosimilar Substitution Bill

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.


ASBM Urges Delaware to Consider Biosimilars Legislation

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.


ASBM Presents EU Survey Findings and Policy Updates at FDLI Annual Conference

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. 

 


ASBM Presents EU Survey Findings and Policy Updates at FDLI Annual Conference

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. 

 


ASBM Attends WHO INN Stakeholders Open Session on Distinguishable Names

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.


ASBM Attends WHO INN Stakeholders Open Session on Distinguishable Names

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.


Multi-stakeholder Perspectives Video on Biosimilar Naming

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 2014 Newsletter

March 31, 2014

ASBM Releases EU Physicians’ Survey in Brussels

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:

  • Only 22% consider themselves as “very familiar” with this new category of medicines…24% “cannot define” or “have not heard about” biosimilars before;
  • 53% of those surveyed incorrectly believed that the same International Nonproprietary Name (INN) meant the products were structurally identical;
  • 72% of prescribers consider it “critical” or “very important” to decide whether a patient should receive an innovator biologic medicine or a biosimilar; as a consequence…
  • 74% consider it “critical” or “very important” that the mention of “dispense as written” on a prescription should be respected; and
  • 62% think that it is “not acceptable” for a pharmacist to determine which biologic medicine to dispense at initiation of a treatment.

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.


58th WHO INN Stakeholder Session Includes ASBM on Agenda

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.


Multi-stakeholder Perspectives Video on Biosimilar Naming

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.


Indiana Governor Signs Biosimilar Legislation

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.


Dolinar to Speak at Discovering Cures Illinois Event

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.


FDLI Annual Conference in April

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.


Upcoming Conferences

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


Indiana Governor Signs Biosimilars Legislation Ensuring Patient Safety

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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Pan-European survey calls for a shift in policy for biosimilars

March 18, 2014

Brussels — Today, the Alliance for Safe Biologic Medicines (ASBM) disclosed the results of a survey of 470 European physicians, that took place in Q3 of 2013, across five EU countries (France, Germany, Italy, Spain, and the UK), 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 physicians and patient groups, as well as industry and regulatory bodies.

One of the main findings of the survey relates to European physicians’ insufficient knowledge of biosimilars. Only 22% consider themselves as very familiar with this new category of medicines. Whilst a majority (54%) have a basic understanding of biosimilars 24% of participants cannot define or have not heard about biosimilars before.

The findings stress that using the same International Non-Proprietary Name (INN) for two medicines (innovator biologic and biosimilar) can be misleading. Firstly, this may lead to false attribution of adverse event if reporters only report the INN, but also it may give the wrong impression that these medicines are structurally identical (54% of those surveyed thought that the same INN meant the products were structurally identical).

Although the results showed that physicians prefer to use brand names when prescribing biological medicines and reporting adverse events, the findings around the use of INN and its meaning in the context of biosimilar products lead us to conclude that the use of distinguishable INN for all biologics, including biosimilars, is critical to further strengthen and facilitate patient safety through effective pharmacovigilance.

The survey also provides important information regarding substitution. 72% of prescribers consider it “Critical” or “Very Important” to decide whether a patient should receive an innovator biologic medicine or a biosimilar. As a consequence, 74% consider it “Critical” or “Very Important” that the mention of “Dispense as Written” on prescriptions should be respected, and 62% think that it is “not acceptable” for a pharmacist to determine which biologic medicine to dispense at initiation of treatment.

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 biologic 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.” He also added that key findings of the survey show that 54% of physicians surveyed only have a basic understanding of biosimilars, and more concerning that 24% cannot define or have not heard about biosimilars before.”

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 maximise patient outcomes. In the coming months, EuropaBio shall commit to raising awareness, through an open dialogue with physicians and regulators, which will include workshops at member state level.”

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About EuropaBio:

EuropaBio is the European Association of BioIndustries. Our members are involved in research, development, testing, manufacturing and commercialisation of biotech products and processes in human and animal healthcare, diagnostics, bioinformatics, chemicals, crop protection, agriculture, food and environmental products and services. EuropaBio also counts a number of National Biotech Associations in its membership who in turn represent more than 1800 biotech SMEs.

ASBM-EuropaBio Roundtable Event

European Physician Survey, Executive Summary

ASBM-European Survey Presentation

ASBM Physician Survey Full Report

GCCA Press Release

Generics Bulletin


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