Senator Hagan writes HHS to issue guidance on naming
July 30, 2014
View letter here.
ASBM member RetireSafe conducts senior survey on knowledge and safety issues concerning biosimilars
July 18, 2014
A new RetireSafe survey, published July 15th, finds seniors largely are unaware of “biosimilar” drugs and overwhelmingly support strong patient safeguards for biosimilar development and FDA approval.
In the survey, senior respondents supported robust clinical trials, unique names for biosimilar drugs, as well as physician and patient notification of biosimilar substitution.
To view the RetireSafe survey information and results, click here.
Pennsylvania has a chance to update its law to allow for biosimilar medicine substitutions – Pittsburgh Post Gazette
July 9, 2014
See article here.
Pennsylvania has a chance to update its law to allow for biosimilar medicine substitutions – Pittsburgh Post Gazette
July 9, 2014
See article here.
EU Commission publishes “What you need to know about biosimilar medicinal products”
July 9, 2014
Translations of the European Commission’s Consensus Information Document on biosimilars is now available in French, German, Italian and Spanish.
The documents were created to foster stakeholders’ understanding of biosimilars in Member States and is a result of a cooperation of all relevant European stakeholders. The papers can be found on the European Commission’s website.
Also to learn more information from ASBM member partner EuropaBio, who helped sponsor the translation, please click here.
June 2014 Newsletter
July 3, 2014
ASBM Shares EU Physician Survey in Paris
Michael Reilly, Executive Director of the Alliance for Safe Biologic Medicines, (ASBM) was featured as an expert panelist at the “Understanding Biologic Medicine: Science, Regulatory Policy and the Changing Dynamics of Biosimilars” event hosted by AbbVie on June 10th in Paris, France.
The two-part event was webcast worldwide and featured a discussion on the scientific and regulatory challenges presented by biologics and biosimilars. Reilly presented the results of the ASBM EU Physician Survey, and also participated in a panel discussion with ASBM Steering Committee member and Co-Chair of the Global Colon Cancer Association, Andrew Spiegel.
Journal Article on ASBM EU Survey Published
The Generics and Biosimilars Initiative (GaBI) Journal published an article on the ASBM EU Survey written by Richard Dolinar, MD Chairman of ASBM and Michael Reilly, Executive Director. GaBI is an independent and peer reviewed academic journal which encompasses all aspects of generic and biosimilar medicine development and use, from fundamental research up to clinical application and policies.
To view ASBM article in GaBI, click here.
EGA Multi-Stakeholder Survey on Biosimilar Sustainability
While in Europe, Executive Director of ASBM Michael Reilly traveled to Brussels, Belgium to attend the European Generic Medicines Association’s (EGA) release of a study identifying some of the challenges to establishing a sustainable biosimilar medicines program in Europe.
The survey included multiple stakeholders including physicians, payers, pharmacists, patients and industry across seven EU countries. According to the study and the EGA’s press release any national policy framework on biosimilars should consider a variety of factors which include: targeted education of all stakeholders, incentives that encourage competition while supporting innovation, the publication of real world evidence to increase safety and efficacy, as well as transparent policies that allow for input without delaying market entry.
To learn more about the EGA study, click here.
Dr. Dolinar Presents at DIA Annual Conference
On June 19th, ASBM Chairman Richard Dolinar, MD presented at the Drug Information Agency’s (DIA) 50th Annual Meeting in San Diego, California.
“Trends in Biosimilars Regulation Within Developed and Emerging Markets” was an assessment of current debates within the regulatory landscape of biosimilars. Dr. Dolinar participated on a panel moderated by Andrew Robertson, Director of U.S. Regulatory Policy at Merck and panelist Sonica Sachdeva, Director of Clinical Development at Dr. Reddy’s Laboratory, India.
Dr. Dolinar shared the results of the ASBM European Prescriber Survey while advocating for distinguishable non-proprietary names for biosimilars. Dr. Sachdeva reviewed how biologics and biosimilars are regulated in Eastern Asia.
View Dr. Dolinar’s presentation here.
ASBM Members Feature Biosimilars at BIO Convention
The Biotechnology Industry Organization (BIO) hosted its International Convention in San Diego, CA on June 23rd-26th.
This year’s convention featured a panel of ASBM members including:
ASBM Steering Committee member Marcia Horn, President and CEO of the International Cancer Advocacy Network (ICAN); ASBM International Advisory Board member and Associate Dean of the University of Arizona College of Pharmacy, Phillip Schneider; and also ASBM International Advisory Board member, Robert Yapundich, MD.
The session entitled, “Ensuring the Safety and Commercial Success of Biosimilars in the United States,” examined how the United States can move forward to ensure patients have access to high quality, safe and effective biosimilars. Panelists discussed the impact of international naming conventions, state substitution policies and other challenges facing regulators, including lessons learned from the European experience with biosimilars.
To view BIO Conference page, click here.
IN THE STATES
Massachusetts Third State to Enact Biosimilars Substitution Bill
Governor Deval Patrick enacted biosimilars legislation on June 24th, updating Massachusetts’s pharmacy law and paving the way for the substitution of biosimilars deemed ‘interchangeable’ by the Food and Drug Administration (FDA). The Governor took such action after swift passage of HB 3724 in both chambers of the legislature.
This new law allows pharmacists to substitute a biosimilar for a brand biologic once the biosimilar is deemed to be ‘interchangeable’. The pharmacists will be required to communicate that a substitution has occurred both to the patient, as well as the prescribing physician. Importantly, physicians will also maintain the right to prohibit substitutions from occurring if the prescriber instructs otherwise in writing. The pharmacy will be required to maintain a record of each substitution for a period of at least a year.
“By ensuring that communication between physicians, pharmacists and patients remains a priority, we can monitor these complex therapies while providing the best quality and care,” concluded ASBM Chairman Richard Dolinar, MD. “We commend Governor Patrick for taking the necessary steps to protect this balance for patients in Massachusetts.”
View ASBM’s full press release here.
Pennsylvania
The Pennsylvania Senate has also recently passed biosimilars legislation. SB 405 was voted out of the Senate by a vote of 44-6 on June 24th. This legislation also addresses FDA approved ‘interchangeable’ biosimilars, and maintains the right of physicians to prohibit substitution, as well as notify the patient of the exchange. However, the language specifically requires physician notification to occur within 72 hours of dispensing, and requires record keeping for at least two years.
It is hoped the House Committee on Health will hear the bill in the fall when it reconvenes.
View legislation here.
BIO President and CEO, James Greenwood, also wrote the Philadelphia Inquirer commenting on the bill and the need for PA to pass biosimilars legislation. Greenwood, who is a former PA State legislator and Member of Congress wrote the Inquirer stating:
“Interchangeable biologics provide additional options for healing debilitating diseases. Pennsylvania lawmakers – and legislators around the country – should do their part to make certain that, when these options become available, nothing prevents patients from obtaining them.”
View Philadelphia Inquirer op-ed here.
ASBM Submits EOI to 59th WHO INN Session
In a letter addressed to Dr. Balocco, International Nonproprietary Names (INN) Manager, ASBM once again submitted an Expression of Interest (EOI) to appear before the Open Session of the 59th (INN) Consultation that will take place on Tuesday, October 14th, 2014.
On behalf of ASBM, Dr. Dolinar has twice appeared before the INN Expert Group, most recently in April 2014. The WHO is expected to publish both an Executive Summary and the next steps for a ‘Biologic Qualifiers’ (BQ) proposal by the end of July 2014.
To visit the WHO INN page, click here.
NORD Advocates for Distinguishable Naming in Letter to FDA
The National Organization for Rare Disorders (NORD) was the second large patient-focused advocacy group to write the U.S. Food and Drug Administration in the past month on the naming of biosimilars as more pressure is being placed on the FDA to establish an opinion on naming.
In the letter, NORD argues that it is particularly important for the tracing of adverse events in the disease populations it represents because many rare disease patients must prove ‘medical necessity’ for treatment and reimbursement. In addition, distinguishable names help doctors more quickly determine which medicines are best for patient, providing individualized care needed for rare diseases.
“Distinguishable names for biologics support the medical community’s vital post-approval learning curve about which medicines are best for their rare disease patients,” the letter to the FDA states.
View NORD press release and letter to FDA here.
NHMA Joins ASBM Ranks and Bolsters Physician Voice in Biosimilars Discussion
This June, ASBM welcomed the National Hispanic Medical Association and it’s president, Elena Rios, MD, MSPH.
Established in 1994, NHMA is a nonprofit association representing 45,000 licensed Hispanic physicians in the United States. NHMA’s mission is to empower Hispanic physicians and other healthcare professionals to improve the health of Hispanic populations with Hispanic medical societies, residents and medical student organizations and its public and private sector partners.
To learn more about the National Hispanic Medical Association, click here.
Upcoming Conferences:
August 13th and 14th: 4th Latin America Forum on Biosimilars, Rio de Janeiro, Brazil
August 24th and 25th: Pre-International Conference of Drug Regulatory Authorities, Rio de Janeiro, Brazil
September 18th and 19th: DIA Biosimilars 2014, Washington, DC
September 20th: European Parkinson’s Disease Association Unity Walk, Luxembourg
June 2014 Newsletter
July 3, 2014
ASBM Shares EU Physician Survey in Paris
Michael Reilly, Executive Director of the Alliance for Safe Biologic Medicines, (ASBM) was featured as an expert panelist at the “Understanding Biologic Medicine: Science, Regulatory Policy and the Changing Dynamics of Biosimilars” event hosted by AbbVie on June 10th in Paris, France.
The two-part event was webcast worldwide and featured a discussion on the scientific and regulatory challenges presented by biologics and biosimilars. Reilly presented the results of the ASBM EU Physician Survey, and also participated in a panel discussion with ASBM Steering Committee member and Co-Chair of the Global Colon Cancer Association, Andrew Spiegel.
Journal Article on ASBM EU Survey Published
The Generics and Biosimilars Initiative (GaBI) Journal published an article on the ASBM EU Survey written by Richard Dolinar, MD Chairman of ASBM and Michael Reilly, Executive Director. GaBI is an independent and peer reviewed academic journal which encompasses all aspects of generic and biosimilar medicine development and use, from fundamental research up to clinical application and policies.
To view ASBM article in GaBI, click here.
EGA Multi-Stakeholder Survey on Biosimilar Sustainability
While in Europe, Executive Director of ASBM Michael Reilly traveled to Brussels, Belgium to attend the European Generic Medicines Association’s (EGA) release of a study identifying some of the challenges to establishing a sustainable biosimilar medicines program in Europe.
The survey included multiple stakeholders including physicians, payers, pharmacists, patients and industry across seven EU countries. According to the study and the EGA’s press release any national policy framework on biosimilars should consider a variety of factors which include: targeted education of all stakeholders, incentives that encourage competition while supporting innovation, the publication of real world evidence to increase safety and efficacy, as well as transparent policies that allow for input without delaying market entry.
To learn more about the EGA study, click here.
Dr. Dolinar Presents at DIA Annual Conference
On June 19th, ASBM Chairman Richard Dolinar, MD presented at the Drug Information Agency’s (DIA) 50th Annual Meeting in San Diego, California.
“Trends in Biosimilars Regulation Within Developed and Emerging Markets” was an assessment of current debates within the regulatory landscape of biosimilars. Dr. Dolinar participated on a panel moderated by Andrew Robertson, Director of U.S. Regulatory Policy at Merck and panelist Sonica Sachdeva, Director of Clinical Development at Dr. Reddy’s Laboratory, India.
Dr. Dolinar shared the results of the ASBM European Prescriber Survey while advocating for distinguishable non-proprietary names for biosimilars. Dr. Sachdeva reviewed how biologics and biosimilars are regulated in Eastern Asia.
View Dr. Dolinar’s presentation here.
ASBM Members Feature Biosimilars at BIO Convention
The Biotechnology Industry Organization (BIO) hosted its International Convention in San Diego, CA on June 23rd-26th.
This year’s convention featured a panel of ASBM members including:
ASBM Steering Committee member Marcia Horn, President and CEO of the International Cancer Advocacy Network (ICAN); ASBM International Advisory Board member and Associate Dean of the University of Arizona College of Pharmacy, Phillip Schneider; and also ASBM International Advisory Board member, Robert Yapundich, MD.
The session entitled, “Ensuring the Safety and Commercial Success of Biosimilars in the United States,” examined how the United States can move forward to ensure patients have access to high quality, safe and effective biosimilars. Panelists discussed the impact of international naming conventions, state substitution policies and other challenges facing regulators, including lessons learned from the European experience with biosimilars.
To view BIO Conference page, click here.
IN THE STATES
Massachusetts Third State to Enact Biosimilars Substitution Bill
Governor Deval Patrick enacted biosimilars legislation on June 24th, updating Massachusetts’s pharmacy law and paving the way for the substitution of biosimilars deemed ‘interchangeable’ by the Food and Drug Administration (FDA). The Governor took such action after swift passage of HB 3724 in both chambers of the legislature.
This new law allows pharmacists to substitute a biosimilar for a brand biologic once the biosimilar is deemed to be ‘interchangeable’. The pharmacists will be required to communicate that a substitution has occurred both to the patient, as well as the prescribing physician. Importantly, physicians will also maintain the right to prohibit substitutions from occurring if the prescriber instructs otherwise in writing. The pharmacy will be required to maintain a record of each substitution for a period of at least a year.
“By ensuring that communication between physicians, pharmacists and patients remains a priority, we can monitor these complex therapies while providing the best quality and care,” concluded ASBM Chairman Richard Dolinar, MD. “We commend Governor Patrick for taking the necessary steps to protect this balance for patients in Massachusetts.”
View ASBM’s full press release here.
Pennsylvania
The Pennsylvania Senate has also recently passed biosimilars legislation. SB 405 was voted out of the Senate by a vote of 44-6 on June 24th. This legislation also addresses FDA approved ‘interchangeable’ biosimilars, and maintains the right of physicians to prohibit substitution, as well as notify the patient of the exchange. However, the language specifically requires physician notification to occur within 72 hours of dispensing, and requires record keeping for at least two years.
It is hoped the House Committee on Health will hear the bill in the fall when it reconvenes.
View legislation here.
BIO President and CEO, James Greenwood, also wrote the Philadelphia Inquirer commenting on the bill and the need for PA to pass biosimilars legislation. Greenwood, who is a former PA State legislator and Member of Congress wrote the Inquirer stating:
“Interchangeable biologics provide additional options for healing debilitating diseases. Pennsylvania lawmakers – and legislators around the country – should do their part to make certain that, when these options become available, nothing prevents patients from obtaining them.”
View Philadelphia Inquirer op-ed here.
ASBM Submits EOI to 59th WHO INN Session
In a letter addressed to Dr. Balocco, International Nonproprietary Names (INN) Manager, ASBM once again submitted an Expression of Interest (EOI) to appear before the Open Session of the 59th (INN) Consultation that will take place on Tuesday, October 14th, 2014.
On behalf of ASBM, Dr. Dolinar has twice appeared before the INN Expert Group, most recently in April 2014. The WHO is expected to publish both an Executive Summary and the next steps for a ‘Biologic Qualifiers’ (BQ) proposal by the end of July 2014.
To visit the WHO INN page, click here.
NORD Advocates for Distinguishable Naming in Letter to FDA
The National Organization for Rare Disorders (NORD) was the second large patient-focused advocacy group to write the U.S. Food and Drug Administration in the past month on the naming of biosimilars as more pressure is being placed on the FDA to establish an opinion on naming.
In the letter, NORD argues that it is particularly important for the tracing of adverse events in the disease populations it represents because many rare disease patients must prove ‘medical necessity’ for treatment and reimbursement. In addition, distinguishable names help doctors more quickly determine which medicines are best for patient, providing individualized care needed for rare diseases.
“Distinguishable names for biologics support the medical community’s vital post-approval learning curve about which medicines are best for their rare disease patients,” the letter to the FDA states.
View NORD press release and letter to FDA here.
NHMA Joins ASBM Ranks and Bolsters Physician Voice in Biosimilars Discussion
This June, ASBM welcomed the National Hispanic Medical Association and it’s president, Elena Rios, MD, MSPH.
Established in 1994, NHMA is a nonprofit association representing 45,000 licensed Hispanic physicians in the United States. NHMA’s mission is to empower Hispanic physicians and other healthcare professionals to improve the health of Hispanic populations with Hispanic medical societies, residents and medical student organizations and its public and private sector partners.
To learn more about the National Hispanic Medical Association, click here.
Upcoming Conferences:
August 13th and 14th: 4th Latin America Forum on Biosimilars, Rio de Janeiro, Brazil
August 24th and 25th: Pre-International Conference of Drug Regulatory Authorities, Rio de Janeiro, Brazil
September 18th and 19th: DIA Biosimilars 2014, Washington, DC
September 20th: European Parkinson’s Disease Association Unity Walk, Luxembourg
EU Approves First Biosimilar Insulin
July 1, 2014
On June 27, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) announced granting of preliminary marketing approval for the European Union’s first biosimilar insulin glargine product.
Called Abasria (LY2963016), the investigational basal (long-acting) insulin is intended for the treatment of type 1 and type 2 diabetes. Abasria, like its reference product, the diabetes drug Lantus (insulin glargine), produced by Sanofi-Aventis, binds to the human insulin receptor and results in the same pharmacological effects as human insulin.
Abasria is produced by Eli Lilly in partnership with Boehringer Ingelheim.
The CHMP’s recommendation follows its manufacturers’ announcement in June that (LY2963016) has demonstrated a similar safety and efficacy profile to Lantus. The results of these studies, first announced at the 74th American Diabetes Association Scientific Sessions held in San Francisco, were specifically cited in the CHMP opinion.
The CHMP’s recommendation for Abasria will now be referred to the European Commission which grants approval for the European Union, Norway and Iceland. The Commission’s final approval is anticipated by September 2014.
Massachusetts Governor Signs Pharmacy Legislation Creating a Pathway for Biosimilars
June 24, 2014
Arlington, VA – Today, Governor Deval Patrick enacted biosimilars legislation updating Massachusetts’s pharmacy law and paving the way for the substitution of biosimilars deemed ‘interchangeable’ by the Food and Drug Administration (FDA). The Governor took such action after swift passage of HB 3724 in both chambers of the General Court of the Commonwealth of Massachusetts.
“As a physician, I applaud the Governor and the legislature for taking action to maintain the careful checks and balances needed in administering biologics,” stated Richard Dolinar, M.D., chairman of the Alliance for Safe Biologic Medicines (ASBM). “Unlike chemical drugs, biologics are complex medicines treating complicated conditions. For that reason, regulations are needed to ensure doctors have a complete knowledge of what medicines are administered to their patients. I feel confident that this new law strikes the right balance in maintaining the safety and efficacy of biologic products, while advancing more treatment options to patients.”
Biosimilars, or copies that are similar to but not exact versions of the original biologic, are expected to be approved by the FDA as early as 2015. While the FDA will deem whether a biologic drug is approved and ‘interchangeable’, it is up to the states to decide whether one product may be substituted at the pharmacy level in place of the original biologic prescribed.
This new law allows pharmacists to substitute a biosimilar for a brand biologic once the biosimilar is deemed to be ‘interchangeable’. The pharmacists would be required to communicate that a substitution has occurred both to the patient, as well as the prescribing physician. Importantly, physicians would also maintain the right to prohibit substitutions from occurring if the prescriber instructs otherwise in writing. The pharmacy will be required to maintain a record of each substitution for a period of at least a year.
Massachusetts is the third state this year to pass biosimilars legislation and pave the way for the substitution of biosimilars. This creates a model for other states to follow in order to address the necessary level of pharmacovigilance, while also promoting the use of these life-enhancing medicines.
“By ensuring that communication between physicians, pharmacists and patients remains a priority, we can monitor these complex therapies while providing the best quality and care,” concluded Dolinar. “We commend Governor Patrick for taking the necessary steps to protect this balance for patients in Massachusetts.”
# # #
Massachusetts Governor Signs Pharmacy Legislation Creating a Pathway for Biosimilars
June 24, 2014
Arlington, VA – Today, Governor Deval Patrick enacted biosimilars legislation updating Massachusetts’s pharmacy law and paving the way for the substitution of biosimilars deemed ‘interchangeable’ by the Food and Drug Administration (FDA). The Governor took such action after swift passage of HB 3724 in both chambers of the General Court of the Commonwealth of Massachusetts.
“As a physician, I applaud the Governor and the legislature for taking action to maintain the careful checks and balances needed in administering biologics,” stated Richard Dolinar, M.D., chairman of the Alliance for Safe Biologic Medicines (ASBM). “Unlike chemical drugs, biologics are complex medicines treating complicated conditions. For that reason, regulations are needed to ensure doctors have a complete knowledge of what medicines are administered to their patients. I feel confident that this new law strikes the right balance in maintaining the safety and efficacy of biologic products, while advancing more treatment options to patients.”
Biosimilars, or copies that are similar to but not exact versions of the original biologic, are expected to be approved by the FDA as early as 2015. While the FDA will deem whether a biologic drug is approved and ‘interchangeable’, it is up to the states to decide whether one product may be substituted at the pharmacy level in place of the original biologic prescribed.
This new law allows pharmacists to substitute a biosimilar for a brand biologic once the biosimilar is deemed to be ‘interchangeable’. The pharmacists would be required to communicate that a substitution has occurred both to the patient, as well as the prescribing physician. Importantly, physicians would also maintain the right to prohibit substitutions from occurring if the prescriber instructs otherwise in writing. The pharmacy will be required to maintain a record of each substitution for a period of at least a year.
Massachusetts is the third state this year to pass biosimilars legislation and pave the way for the substitution of biosimilars. This creates a model for other states to follow in order to address the necessary level of pharmacovigilance, while also promoting the use of these life-enhancing medicines.
“By ensuring that communication between physicians, pharmacists and patients remains a priority, we can monitor these complex therapies while providing the best quality and care,” concluded Dolinar. “We commend Governor Patrick for taking the necessary steps to protect this balance for patients in Massachusetts.”
# # #
