American Academy of Dermatology Updates Biosimilar Statement

August 15, 2013

This month, the AADA’s Board of Directors approved an updated version of their position statement on biosimilars.  The AADA specifically adds new language to clarify physician notification by pharmacists. Read full statement here.


American Academy of Dermatology Updates Biosimilar Statement

August 15, 2013

This month, the AADA’s Board of Directors approved an updated version of their position statement on biosimilars.  The AADA specifically adds new language to clarify physician notification by pharmacists. Read full statement here.


European Medicines Agency recommends approval of first two monoclonal-antibody biosimilars

July 29, 2013

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.


European Medicines Agency recommends approval of first two monoclonal-antibody biosimilars

July 29, 2013

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.


Biosimilars Policy Forums

July 25, 2013

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.

_________________________________________________________________________________________________

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.

 


ASBM Presents in Geneva, International Alliance of Patients’ Organizations (IAPO)

July 25, 2013

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.


ASBM Presents in Geneva, International Alliance of Patients’ Organizations (IAPO)

July 25, 2013

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.


Dolinar Adds to the Emerging Consensus Among Stakeholders on the Need for Unique Names

July 25, 2013

June 26, 2013

In Ottawa, Alliance for Safe Biologic Medicines (ASBM) chairman, Richard Dolinar M.D., was one of a small group of patient advocates invited to address international regulators at the “Regulator Forum on Biologic Naming and Traceability,” hosted by Health Canada and BIOTECanada.  Dolinar’s presentation added a physician’s perspective to the emerging consensus that unique distinguishable INN names play a central role in pharmacovigilance and traceability systems that enable clearer communication with patients, medical staff and pharmacists.

“Biologics are highly sensitive to the manufacturing process and their environment; slight differences can have unexpected results,” stated Dr. Dolinar.  “As a physician, patient safety is paramount. I need to know as quickly as possible when and which product is associated with an unexpected outcome in order to treat my patients effectively.  Identical names imply identical products, which will not be the case when biologics are made using different manufacturing processes and/or cell lines.  If distinct non-proprietary names are not given to products, we may waste valuable treatment time trying to identify the root cause, and the patient will suffer.”

Read more here.


Dolinar Addresses DIA: Quality, Manufacturing Transparency Key to Avoiding Drug Shortages

July 25, 2013

June 24, 2013

Speaking at the 49th Annual Drug Information Association (DIA) Conference in Boston, Richard Dolinar, M.D., presented an analysis of past drug shortages and discussed how policies toward biologic drugs can be developed to guard against short supply.  Dolinar’s presentation, entitled “Characterizing Drug Shortages and Their Causes: Anticipated Future Trends,” stresses that quality and consistency are vital for ensuring a steady and safe supply of biologic medicines for patients.

“It is important for prescribers to understand how policies toward biologic drugs are taking shape and why manufacturing quality remains key to supply,” said Dr. Dolinar, a practicing endocrinologist. “Biologics are incredibly complex and as such not yet well understood, but we can avoid the pitfalls of the past by developing sound policy that centers on patient safety and efficacy.”

Read more here.


June 2013 Newsletter

July 24, 2013

Inside Health Policy: “Safety, Generic Concerns Factors in Proposed AMA Biosimilar Resolution”

A perceived lack of safety information about biosimilars and past problems with substitution of generic drugs led neurologists and rheumatologists to ask the American Medical Association to study the safety of follow-on biologics. AMA is expected to considerer the topic further at a medical group meeting next week.


European Medicines Agency Recommends Approval of First Two Monoclonal Antibody Biosimilars

The European Medicines Agency is reporting that its Committee for Medicinal Products for Human Use has recommended granting of marketing authorisations for Remsima and Inflectra, both containing the same known active substance, Infliximab. These two new biologics are recommended for the same indications as Remicade, covering a range of autoimmune diseases such as rheumatoid arthritis and Chron’s disease amongst others.

Read more here.


Dolinar Adds to the Emerging Consensus Among Stakeholders on the Need for Unique Names

Last week in Ottawa, Alliance for Safe Biologic Medicines (ASBM) chairman, Richard Dolinar M.D., was one of a small group of patient advocates invited to address international regulators at the “Regulator Forum on Biologic Naming and Traceability” hosted by Health Canada and BIOTECanada. Dolinar’s presentation added a physician’s perspective to the emerging consensus that unique distinguishable INN names play a central role in pharmacovigilance and traceability systems that enable clearer communication with patients, medical staff and pharmacists.

“Biologics are highly sensitive to the manufacturing process and their environment; slight differences can have unexpected results,” stated Dr. Dolinar at the event. “As a physician, patient safety is paramount. I need to know as quickly as possible when and which product is associated with an unexpected outcome in order to treat my patients effectively. Identical names imply identical products, which will not be the case when biologics are made using different manufacturing processes and/or cell lines. If distinct non-proprietary names are not given to products, we may waste valuable treatment time trying to identify the root cause, and the patient will suffer.”

Read more here.


ASBM Video Feature for Canada’s Globe and Mail

Executive Director Michael Reilly participated in a taping for Globe and Mail, Canada’s national newspaper which has been in print for 167 years. Reilly joined Karen Burke of Amgen, and Jackie Manthorne from the Canadian Cancer Survivors Network in a video series of vignettes that will introduce the Globe and Mail audience to the emerging issue of biosimilars. In his piece, Reilly focused on the unique process in creating biosimilars, as well as spoke to the regulatory policies in development in Canada, the EU and the US.

These compelling videos, which are expected to be released in the next month or so, are easy briefings and sharable via social media.


EuropaBio joins the Alliance for Safe Biologic Medicines

The Alliance for Safe Biologic Medicines is pleased to announce the addition of EuropaBio to its membership.

EuropaBio is the European Association for Bioindustries, bringing together bioscience companies from all fields of research and development, testing, manufacturing and distribution of biotechnology products. It has 56 corporate members, 14 associate members and Bio Regions and 19 National Biotechnology Associations – representing some 1800 small and medium sized enterprises across Europe.

“With the partnership of EuropaBio, the Alliance for Safe Biologic Medicines can continue to ensure the affordability and accessibility of biologic medications while never compromising on patient safety, here in the US and across the globe.” stated Dr. Richard Dolinar, Chairman of the ASBM. “We are pleased to have such an authoritative international partner who will add their voice to important policy decisions surrounding safety and efficacy for patients as more biologics become available.”

“EuropaBio member companies are highly committed to deliver safe biologic medicines to the patient. We work together with biologic and biosimilar manufacturers, health care professionals, patient groups and other key stakeholders to ensure patient safety is at the forefront of the biosimilars policy discussion,” commented EuropaBio Biosimilar topic group leader Stefan Bergunde.


White Paper Compares US and EU Regimes

A white paper entitled, “A Comparison of US and EU Regimes,” authored by Michael J. Shuster, Ph.D., Partner of the Intellectual Property Group and Co-Chair of the Life Science Group and Associate Pauline Farmer-Koppenol, MS of the Intellectual Property Group, was recently released by Fenwick & West, LLP. The article presents an overview of their biosimilars regulations, in order to help legal and executive decision makers at biopharmaceutical companies begin to think about the range of expenditures that may be necessary for approval of a biosimilar.

View full white paper here.


ASBM Participates in BioWorld Webinar

Executive Director of ASBM, Michael Reilly recently moderated “The Promise of Biosimilars for the Biotech Industry: Opportunities and Challenges of this Emerging Market,” an educational webinar hosted by BioWorld Today. Presenters included, Sheila D. Walcoff, JD, a health-policy expert formally with HHS and the founding principal of Goldbug Strategies LLC; and Dirk Reitsma, MD, Vice President and Head of Oncology Global Product Development at PPD, who has extensive clinical development experience.

The webinar consisted of a 60-minute presentation focused on the emerging US policy on biosimilars as well as the scientific factor in determining interchangeability, followed by a question and answer session.


Dolinar Addresses DIA: Quality, Manufacturing Transparency Key to Avoiding Drug Shortages

Speaking at the 49th Annual Drug Information Association (DIA) Conference in Boston, Dr. Richard Dolinar, presented an analysis of past drug shortages and discussed how policies toward biologic drugs can be developed to guard against short supply. Dolinar’s presentation, entitled “Characterizing Drug Shortages and Their Causes: Anticipated Future Trends,” stresses that quality and consistency are vital for ensuring a steady and safe supply of biologic medicines for patients.

“It is important for prescribers to understand how policies toward biologic drugs are taking shape and why manufacturing quality remains key to supply,” said Dr. Dolinar, a practicing endocrinologist. “Biologics are incredibly complex and as such not yet well understood, but we can avoid the pitfalls of the past by developing sound policy that centers on patient safety and efficacy.”


International Leaders Added to ASBM Advisory Board

Professor Stavljenić-Rukavina, Vice Dean for Science at the Dubrovnki International University has officially joined ASBM as an International Advisory Board Member as a result of ASBM’s presence in Geneva. Professor Rukavina has spent many years as a professor at the University of Zagreb School of Medicine, and is a founder of the Croatian Association for Quality in Health Care. She has had a varied career as a politician (served as Minister of Health), academic and consultant.

ASBM is also pleased to add Dr. Victoria Pinkney-Atkinson, Executive Director of the Patient Health Alliance of Nongovernmental Organisations (PHANGO) in South Africa and Virginia Ladd, President of the American Autoimmune Related Diseases Association.


State Legislation Update

ASBM has remained diligent in supporting patient-focused legislation on biosimilar substitution, particularly in California and Delaware.

In California, SB 598 has been under consideration in the State Assembly where it was double referred to the Assembly Business, Professions and Consumer Protections Committee and the Assembly Health Committee. SB 598 passed both committees and is now expected to go to the Appropriations Committee for a pro forma vote, since it should have no fiscal impact.

ASBM and its individual partners have also submitted letters in support of SB 118 under consideration in Delaware. The legislation was reported out of the Senate Sunset Committee on June 18th with a favorable vote. Currently, SB 118 is in a holding pattern and is expected to be at the top of the agenda starting in 2014.



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