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ASBM and Patient Advocates Write FDA on Naming

August 14th, 2014

The Alliance for Safe Biologic Medicines (ASBM), along with dozens of patient organizations, write Commissioner Hamburg to encourage the FDA to adopt a policy of distinguishable nonproprietary names for biosimilars and to issue guidance reflecting distinguishable naming as a priority for the well-being of patients.

Read full letter here.

ASBM Names Harry L. Gewanter, MD as Incoming Chairman; Dean Philip Schneider as International Advisory Board Chair

August 7th, 2014

ARLINGTON, VA – Michael Reilly, executive director of the Alliance for Safe Biologic Medicines (ASBM) today announced pediatric rheumatologist and current ASBM International Advisory Board (IAB) member, Harry L. Gewanter, MD, FAAP, FACR as ASBM’s incoming chairman. In addition, Philip Schneider, MS, FASHP, Professor and Associate Dean at the University of Arizona, College of Pharmacy will serve as the International Advisory Board Chair. Dr. Schneider has served on the ASBM advisory board since September 2012.

“As a member of our International Advisory Board for three years, Dr. Gewanter has been instrumental in helping to craft ASBM’s policy recommendations and has taken an active role in its policy development and education efforts,” said Reilly. “We are excited for Dr. Gewanter to take a more prominent role within the organization and utilize his expertise to forward ASBM’s mission.”

Dr. Gewanter succeeds outgoing chairman Richard Dolinar, MD, who served as ASBM’s initial chairman since 2011. Dolinar has testified before the U.S. Food and Drug Administration (FDA) and the World Health Organization’s (WHO) International Nonproprietary Naming Consultation, as well as appeared as a global keynote speaker.

“Dr. Dolinar oversaw the creation, growth and maturation of ASBM — from an organization focused on shaping the biosimilar approval pathway in the United States to an internationally recognized voice that speaks for patient’s with serious chronic illnesses and the physicians who care for them,” said Dr. Gewanter. “During his tenure, Dr. Dolinar has assisted regulatory bodies as they craft international standards for biosimilars. I look forward to continuing his work as chairman and elevating the voice of patients and physicians in global regulatory decisions to provide patients and physicians additional safe and effective treatment options and greater transparency as biosimilars enter the marketplace.”

“Dr. Dolinar has been an outstanding leader in the education of physicians, patients and policymakers alike in the relatively new arena of biologics and biosimilars,” stated Reilly. “Under his leadership, our membership and impact has grown and we are grateful for his guidance of ASBM.”

Philip Schneider, will also serve ASBM in a new capacity as IAB Chair. During his tenure on ASBM’s Advisory Board, Dr. Schneider has helped educate policymakers on the importance of developing biosimilar policies that encourage collaboration between pharmacists and physicians.

“Pharmacists have an important role to play in the discussion of how biosimilars are treated and we are also the linchpin between patients and the medicines they take, ” stated Schneider. “I look forward to ensuring the pharmacy setting is equipped with the regulations needed to both ensure the safe administration of biosimilars, as well as provide access to potentially lower-cost alternatives to patients.”

Dr. Gewanter and Dr. Schneider will continue ASBM’s global advocacy for policies aimed at ensuring that patients worldwide receive the biologic they were prescribed, that biosimilars are held to high standards of safety and efficacy, and that these medicines can be reliably tracked for adverse events. Gewanter and Schneider will assume their positions on September 1.

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ASBM Letter to Idaho Board of Pharmacy

August 6th, 2014

The Idaho Board of Pharmacy held a hearing on August 5th and 6th regarding proposed regulations for the treatment of biosimilars in their state.  View ASBM letter here.

Senate HELP Committee authors letter to HHS Secretary on biosimilars issues

August 1st, 2014

View letter here.

Senator Hagan writes HHS to issue guidance on naming

July 30th, 2014

View letter here.

ASBM member RetireSafe conducts senior survey on knowledge and safety issues concerning biosimilars

July 18th, 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 9th, 2014

See article here.

EU Commission publishes “What you need to know about biosimilar medicinal products”

July 9th, 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.

EU Approves First Biosimilar Insulin

July 1st, 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 24th, 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.”

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