Safe Biologics

ASBM Chairman Richard Dolinar, MD recently submitted another letter on naming to the World Health Organization Director-General, Dr. Margaret Chan, as well as the INN Expert Group, Department of Essential Medicines & Health Products, and the Health Systems & Innovation division at WHO.  The second letter is a result of ASBM’s keen interst in the 56th Consultaion on International Nonproprietary Names (INN) for Pharmaceutical Substances, which was held in May,  as well as the positive feedback ASBM received from Dr. Raffaella Balocco, INN Program Manager.

Read letter here.

ASBM Chairman Richard Dolinar, MD recently submitted another letter on naming to the World Health Organization Director-General, Dr. Margaret Chan, as well as the INN Expert Group, Department of Essential Medicines & Health Products, and the Health Systems & Innovation division at WHO.  The second letter is a result of ASBM’s keen interst in the 56th Consultaion on International Nonproprietary Names (INN) for Pharmaceutical Substances, which was held in May,  as well as the positive feedback ASBM received from Dr. Raffaella Balocco, INN Program Manager.

Read letter here.

Recommendation marks extension of biosimilar concept to new product class

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting of marketing authorisations for the first two monoclonal-antibody biosimilars.

Remsima and Inflectra both contain the same known active substance, infliximab. In the application dossiers, they have been shown to be similar to the biological medicine Remicade, a monoclonal antibody that has been authorised in the European Union since 1999. Remsima and Inflectra are recommended for authorisation in the same indications as Remicade, covering a range of auto-immune diseases such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and and psoriasis.

Monoclonal antibodies are structurally complex substances that can locate and bind to specific molecules, in the case of infliximab to tumour necrosis factor (TNF) alpha, a protein promoting inflammatory response, which causes many of the clinical problems associated with auto-immune disorders. It is the first time that the biosimilar concept has been successfully applied to such a complex molecule, resulting in the recommended approval of a biosimilar version of infliximab. The biosimilar concept foresees that a biological medicine can be authorised if it can be demonstrated that it is a close copy of a biological medicine that has already been authorised for use in the European Union.

Since the approval of the first biosimilar medicine in Europe in 2006, the regulatory framework in place for the approval of biosimilars has produced a total of 12 authorised biosimilar medicines. The framework consists of a number of overarching guidelines which define and describe key concepts of biosimilar development programmes. The overarching guidelines are complemented by product-specific guidelines, which give more detailed guidance to applicants in relation to the respective class of products.

The product-specific guideline for monoclonal antibodies has been in force since December 2012. As for all biosimilars, the emphasis in the development programme is on demonstrating comparability to the reference medicine. An applicant has to submit studies to the Agency that show that the medicine is a biosimilar of the reference medicine, i.e. that it does not have any meaningful differences from the reference medicine in terms of its quality, safety and efficacy.

Applicants are also required to implement a risk-management plan to confirm the long-term efficacy and safety of a biosimilar, including the detection of any unexpected rare adverse effects when the medicine is used in clinical practice.

The CHMP opinions on Remsima and Inflectra will now be sent to the European Commission for adoption of a marketing-authorisation decision.

Recommendation marks extension of biosimilar concept to new product class

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting of marketing authorisations for the first two monoclonal-antibody biosimilars.

Remsima and Inflectra both contain the same known active substance, infliximab. In the application dossiers, they have been shown to be similar to the biological medicine Remicade, a monoclonal antibody that has been authorised in the European Union since 1999. Remsima and Inflectra are recommended for authorisation in the same indications as Remicade, covering a range of auto-immune diseases such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and and psoriasis.

Monoclonal antibodies are structurally complex substances that can locate and bind to specific molecules, in the case of infliximab to tumour necrosis factor (TNF) alpha, a protein promoting inflammatory response, which causes many of the clinical problems associated with auto-immune disorders. It is the first time that the biosimilar concept has been successfully applied to such a complex molecule, resulting in the recommended approval of a biosimilar version of infliximab. The biosimilar concept foresees that a biological medicine can be authorised if it can be demonstrated that it is a close copy of a biological medicine that has already been authorised for use in the European Union.

Since the approval of the first biosimilar medicine in Europe in 2006, the regulatory framework in place for the approval of biosimilars has produced a total of 12 authorised biosimilar medicines. The framework consists of a number of overarching guidelines which define and describe key concepts of biosimilar development programmes. The overarching guidelines are complemented by product-specific guidelines, which give more detailed guidance to applicants in relation to the respective class of products.

The product-specific guideline for monoclonal antibodies has been in force since December 2012. As for all biosimilars, the emphasis in the development programme is on demonstrating comparability to the reference medicine. An applicant has to submit studies to the Agency that show that the medicine is a biosimilar of the reference medicine, i.e. that it does not have any meaningful differences from the reference medicine in terms of its quality, safety and efficacy.

Applicants are also required to implement a risk-management plan to confirm the long-term efficacy and safety of a biosimilar, including the detection of any unexpected rare adverse effects when the medicine is used in clinical practice.

The CHMP opinions on Remsima and Inflectra will now be sent to the European Commission for adoption of a marketing-authorisation decision.

ASBM continues to participate in and lead forums across the country to educate patients, physicians, pharmacists and policymakers on the U.S. Food and Drug Administration’s (FDA) efforts to bring biosimilars to patients in the U.S.  The intent of the campaign is to highlight the complex nature of biologics, the precise methods and processes required to manufacture them and the challenges presented in the attempt to replicate their structure as the FDA mover forward to create a pathway for biosimilars.

Rhode Island

On December 13, 2012, ASBM co-hosted an educational forum with the University of Rhode Island, College of Pharmacy in Kingston.   Prior to the forum, ASBM members participated in a tour of a nearby biologics facility to see first-hand the intricate process of manufacturing biologic medicines.

At the forum, Ron Jordan, Dean of the College of Pharmacy and ASBM Chairman, Richard Dolinar, M.D. discussed how biologics differ from traditional drugs in the fact that biologics are larger more complex molecules, made in proteins and are difficult to replicate.  The speakers stressed the importance of the physician and pharmacy communities working together to ensure that processes are put in place to ensure patient safety remain paramount.

Participants included:

Richard Dolinar, MD, ASBM Chairman

Andrew Spiegel, CEO of the Colon Cancer Alliance

Ronald Jordan, Dean of the University of Rhode Island – College of Pharmacy

Bruce Babbitt, PAREXEL Consulting

Doug Kraus, patient advocate

View Dr. Dolinar’s presentation. (Biosimilars: A framework to ensure safe substitution)

Read ASBM press release.

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COLORADO

On December 6, 2013, Chairman Richard Dolinar, M.D., and Executive Director Michael Reilly toured a biologic manufacturing facility in Longmont, CO. Several ASBM members also participated on the tour, which was arranged to help attendees better understand the complexities of manufacturing biologics.

After touring the facility, the group attended a forum co-hosted by Colorado BioScience, BIO and ASBM, which discussed the need for stringent standards when manufacturing attempted copies of biologics known as biosimilars. Also discussed was recently introduced Colorado legislation that is intended to ensure that automatic substitution of biosimilars only be allowed when the FDA designates an approved biosimilar as interchangeable.

“As a practicing physician, I am often reminded of the differences biologics can make in the lives of my patients, but today was an eye-opening experience as I witnessed firsthand the immense detail and the stringent standards that are required to ensure that biologics are safe and effective,” said Dr. Dolinar.

Participants included:

Richard Dolinar, MD, ASBM Chairman

Andrew Spiegel, CEO of the Colon Cancer Alliance

Philip Schneider, Associate Dean of the College of Pharmacy at the University of AZ

Fritz Bittenbender, VP of Alliance Development and State Government Affairs at BIO

View Dr. Dolinar’s presentation.

Read ASBM press release.

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ARIZONA

On September 27, 2012, the Alliance for Safe Biologic Medicines (ASBM), the International Cancer Advocacy Network (ICAN) and AZBio hosted “Biosimilars Policy Forum: Ensuring Patient Safety.” The forum, held at the Flinn Foundation in downtown Phoenix, brought together patients, physicians, pharmacists, researchers and other stakeholders to discuss the complex challenges the Food and Drug Administration (FDA) faces as it seeks to establish a regulatory pathway that will lead to the approval of biosimilars in the U.S.

Panelists agreed that patient-safety is and should remain the focal point of efforts to bring biosimilars to the U.S. and that healthcare providers, especially physicians and pharmacists, must work to seek common ground on issues like notification and substitution.  It was also generally agreed that there is an information deficit with the general public about these new innovative medicines, and that the forum was a great start to closing that gap.

Participants included:

Richard Dolinar, MD, ASBM Chairman

Patricia Lucente, Colon Cancer Alliance

Joan Koerber-Walker, CEO of AZBio

Philip J. Schneider, Associate Dean of the University of Arizona College of Pharmacy

Eric Thompson, PhD, Director of Biomarker Research for Paradigm and International Genomics Consortium

Brett Johnson, PhD, International Cancer Advocacy Network

View Dr. Dolinar’s presentation. (Ensuring Patient Safety)

Read ASBM press release.

On May 2, 2013, in Geneva Switzerland, the International Alliance of Patients’ Organizations (IAPO) hosted a gathering of 21 health consumer organizations for a workshop on biosimilar medicines.

Executive Director of ASBM, Michael Reilly, Andrew Spiegel, Co-Chair of the Global Colon Cancer Alliance and Stephen Murby, Board Member of Consumers Health Forum in Australia participated in the workshop, along with speakers such as Dr. Hye-Na-Kang of the World Health Organization and Dr. Pekka Kurki of the Finnish Medicines Agency.

Reilly opened the two-day conference by giving an overview presentation on biologics and the progress being made to introduce biosimilars to patients in the U.S.  In his presentation, he stated that ASBM not only seeks to learn from, but to partner with patients in the EU and Canada to advocate globally for safe, affordable biologics.  Potential areas for creating a global standard include minimally acceptable approval standards, a clearly identifiable and unique naming approach and substitution policies that empower patients and physicians and lead to a sound pharmacovigilance system.

To view Reilly’s presentation click here.

To view Stephen Murby paper click here.

To view Andrew Spiegel’s Case Study on Patient Advocacy for IAPO click here.

On May 2, 2013, in Geneva Switzerland, the International Alliance of Patients’ Organizations (IAPO) hosted a gathering of 21 health consumer organizations for a workshop on biosimilar medicines.

Executive Director of ASBM, Michael Reilly, Andrew Spiegel, Co-Chair of the Global Colon Cancer Alliance and Stephen Murby, Board Member of Consumers Health Forum in Australia participated in the workshop, along with speakers such as Dr. Hye-Na-Kang of the World Health Organization and Dr. Pekka Kurki of the Finnish Medicines Agency.

Reilly opened the two-day conference by giving an overview presentation on biologics and the progress being made to introduce biosimilars to patients in the U.S.  In his presentation, he stated that ASBM not only seeks to learn from, but to partner with patients in the EU and Canada to advocate globally for safe, affordable biologics.  Potential areas for creating a global standard include minimally acceptable approval standards, a clearly identifiable and unique naming approach and substitution policies that empower patients and physicians and lead to a sound pharmacovigilance system.

To view Reilly’s presentation click here.

To view Stephen Murby paper click here.

To view Andrew Spiegel’s Case Study on Patient Advocacy for IAPO click here.