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.
July 9th, 2014
See article here.
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.
July 1st, 2014
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.
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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June 19th, 2014
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 presentation here.
June 10th, 2014
Michael Reilly, Executive Director of the Alliance for Safe Biologic Medicines, (ASBM) was featured as an expert panelist at “Understanding Biologic Medicine: Science, Regulatory Policy and the Changing Dynamics of Biosimilars”, a media briefing 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. Mr. 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.
Mr. Reilly’s presentation can be viewed here.
June 5th, 2014
On June 5, The Generics and Biosimilars Initiative Journal published a paper authored by ASBM’s Chairman Richard Dolinar, MD and its Executive Director Michael Reilly.
The paper is based on data collected by ASBM for its 2013 survey of 470 prescribing physicians with clinical experience using biologics and biosimilars. Respondents included specialists from five Western European countries: the United Kingdom, France, Germany, Italy, and Spain.
The responses demonstrated a need for further education about the nature of biosimilars, and underscored the need for biosimilars to have distinguishable nonproprietary names from their reference products.
Of the physicians surveyed, 53 percent mistakenly believed an identical nonproprietary name implies identical structure; and 61 percent said that identical nonproprietary names imply that the medicines are approved for the same indications, which may not be the case.
Additionally, 24 percent of respondents said they recorded only the nonproprietary name of the biological product in the patient record. Without unique nonproprietary names to distinguish biosimilars from their reference products, this could result in pooling of adverse events, misattribution, and other difficulties.
The survey was conducted in November of 2013, and its results were presented by ASBM to the World Health Organization as part of its 58th Consultation on International Nonproprietary Names in April.
View GaBI paper here.
May 21st, 2014
In a letter dated May 21 to FDA Commissioner, Margaret Hamburg, the Society for Women’s Health Research (SWRA) along with over 40 other organizations, asked the FDA to consider gender disparities when it comes to biosimilars policies.
“As FDA finalizes critical policy issues relating to bringing the first biosimilars to market in the U.S. we ask that you give serious consideration to the impact of these policies on women’s health. Women are often underrepresented in clinical trials, and even when they are included clinical results are not routinely analyzed by sex. Accordingly, the long-term effects and adverse reactions of biologics on female patients is not known.
Distinguishable names will lead to better health outcomes for women by enabling the gathering of sufficient data to ultimately allow providers to fully understand how all biologics – including biosimilars – are performing for women.”
To view letter to the FDA click here.
May 9th, 2014
In a letter to FDA Commissioner Margaret Hamburg dated April 24, U.S. Rep. Anna Eshoo (D-CA) requested an update on FDA’s timeline for releasing guidance on biosimilar naming and interchangeability.
To read letter, click here.