March 1st, 2014
The Alliance for Safe Biologic Medicines submitted comments to the Federal Trade Commission in regards to the “Follow-On Biosimilars Workshop: Impact of Recent Legislative and Regulatory Naming Proposals on Competition” hearing held in February. Read comments here.
February 1st, 2014
Opinion piece by Dr. Sol De Jesus in the Lebanon Daily News. Read here.
January 17th, 2014
“The Physician’s Perspective: A health policy brief from the Institute for Patient Access,” discusses the importance of a doctor’s need to know when their patients are switched to a biosimilar –- an issue public policy makers in the states are currently considering.
Read more here.
November 22nd, 2013
Dublin, Ireland – The Alliance for Safe Biologic Medicines (ASBM) today released the results of a new survey on European physicians’ views on biosimilar naming. ASBM Executive Director Michael Reilly presented the findings at the Drug Information Association (DIA) Biosimilars Workshop in Dublin, Ireland. The key findings showed that nonproprietary names matter to patient safety.
The survey examined responses from more than 470 prescribers located in the United Kingdom, France, Germany, Italy and Spain. The respondents included nephrologists, rheumatologists, dermatologists, neurologists, endocrinologists, and oncologists – all specialties that prescribe biologics.
Key findings from the survey include:
In September 2012, ASBM conducted a similar survey that examined practices and perspectives on biosimilar naming and substitution of over 350 physicians in the U.S. The survey was intended to provide data to help support the U.S. Food and Drug Administration (FDA) as they determine biosimilar policies that will have a fundamental impact on patient safety.
Unlike physicians in the U.S., where biosimilars are not yet available, the perspective of European physicians reflects hands-on clinical experience with biosimilars in a therapeutic setting.
The responses of the European physicians demonstrate the need for distinguishable nonproprietary names to be given for all biologics. Biosimilars, in contrast to generic drugs, may have different structure and therapeutic profile, and be approved for different indications than the reference product.
In his presentation, Reilly noted the commonality of physicians’ views across the ocean despite the significant difference in their respective experience with biosimilars since biosimilars have been on the market in Europe for several years but are not yet approved in the U.S.
“The consistency of physician perspective in the U.S. and Europe with regard to nonproprietary naming of biologics is striking. Identical nonproprietary names are generally understood to mean that the products are both identical and approved for the same indications – incorrect and potentially unsafe assumptions for biologics.
“More and more biologic medicines, both innovative and biosimilar, are being approved around the world. How these products are named will clearly play an important role in facilitating global pharmacovigilance and the safe use of these medicines.”
Both surveys were conducted by Industry Standard Research. European Survey data will be shared in the participating countries following the upcoming holiday season.
About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.
For more information, please contact:
Alliance for Safe Biologic Medicines
November 21st, 2013
Dr. Dolinar discusses biosimilars with Seth Ginsberg of the Global Healthy Living Foundation on WFAS AM 1230 talk radio, Greater NYC. Listen
November 15th, 2013
The Alliance for Patient Access (AfPA) held their National Physicians Biologics Working Group Meeting on November 15-16 in Chicago, IL where Dr. Dolinar gave the keynote address to attending physicians. In his address, Dr. Dolinar discussed the current state of biosimilars and explained the disconnect between the science and potential policies and how they will impact patient safety.
View presentation here.
November 6th, 2013
On October 26, Dr. Richard Dolinar served as the keynote luncheon speaker at the National Association of Latino Elected and Appointed Officials (NALEO) Legislative Summit on Health in Las Vegas. Dr. Dolinar discussed the science and policy issues surrounding biosimilar provisions of the Patient Protection and Affordable Care Act with state legislators from across the country. He explained the differences between traditional chemical drugs and live biologics – stressing the fact that when attempting to replicate biologics, biosimilars, are similar to, but not exact versions of the biologic they aim to replicate and therefore they may act differently in the body.
Dr. Dolinar also gave background on the legislative battles states are facing and the need to prioritize patient safety as biosimilars are approved.
October 28th, 2013
The Alliance for Safe Biologic Medicines (ASBM) executive director, Michael Reilly, was featured in a Globe & Mail video series on biosimilars. Mr. Reilly provides a global perspective on biosimilars, with a focus on why manufacturing matters. Globe & Mail is the national newspaper for Canada and this new online series will provide viewers with easy to watch videos to help inform Canadians on the future of biosimilars.
In the video, Mr. Reilly says:
“The Alliance for Safe Biologic Medicines is trying to bring a global perspective to the issues around biologic medicines, biosimilars, and patient safety. Biologics are the future of medicine and one of the greatest challenges we face is the need to educate.
“We’re going to make sure that we focus first on patient safety and we believe that by doing that we will end up giving a longer term viability for the program of biosimilars as a result.”
Watch the video.
Other video participants included Karen Burke from Amgen Canada who provided a general perspective on biosimilars and Jackie Manthorne, CEO from the Canadian Cancer Survivor Network, who provided the patient perspective.
October 28th, 2013
Allow ‘biosimilars’ in Pennsylvania
These medications will improve health and cut costs
The Pennsylvania Legislature is considering a measure to make sure patients have safe access to an important new class of drugs called “biosimilars.” If the bill passes, Pennsylvania will follow North Dakota, Oregon, Utah and Virginia in taking this critical legislative action.
“Biosimilars” are copycat versions of biological drugs, and the Food and Drug Administration is slated to begin approving these highly effective treatments next year. They’re expected to hit pharmacy shelves costing about 30 percent less than the brand-name medicines they’re based on. The benefits for patients, especially those suffering from cancer and other debilitating illnesses, could be enormous.
However, biosimilars do present some unique health risks. The immense chemical complexity that makes them so powerful can also, on occasion, generate adverse auto-immune responses. The Pennsylvania bill accounts for that medical reality and requires a simple, commonsense safeguard: Physicians and their patients should be notified in the event a pharmacist swaps out a prescribed biologic for its biosimilar alternative.
Unfortunately, critics have successfully framed this legislative push as nothing more than brand-name drug manufacturers using the power of law to block generic competition. They say notification would arouse patients’ suspicions and make them nervous to take low-cost biosimilars, causing many to opt for the more expensive brand-name treatments.
Not true. The bill is based in good science. It wouldn’t dictate the treatment protocols of doctors. It wouldn’t constrain the availability of biosimilars. And it wouldn’t dissuade patients from choosing viable low-cost options. All this legislation would do is provide people with the information they need to make good health care decisions.
Unlike chemical pharmaceuticals, biological medicines are constructed from living material. They typically replace or modify the natural activity of substances native to the human body, such as enzymes, hormones or antibodies. As a result, biologics can be considerably more effective than the pills in your medicine cabinet.
These advanced medicines are particularly important in the fight against cancer. By selectively targeting specific aspects of cancer cells, biologics kill fewer healthy cells and minimize toxic side effects. Some even help develop the red and white blood cells critical to a healthy immune system.
At the Global Colon Cancer Alliance, we assist more than 600,000 patients each year through awareness and support programs. So we’re eager to see copycat biologics hit the market.
In the United States, cancer is the cause of nearly a quarter of all deaths. Colon cancer is the second most deadly form. More than 150,000 Americans are diagnosed with the disease annually and more than 50,000 will die from it. Cutting-edge biologics offer those suffering from this and other forms of cancer new treatment options and improved hope for survival – but only if they are administered safely and accurately.
Biologics are so powerful because they are so much more complicated than traditional treatments. The average biologic molecule is about 1,000 times larger than a molecule from a typical chemical drug. Biologics are so profoundly complex that it’s effectively impossible to make an exact duplicate.
A traditional pharmaceutical is produced via a straightforward manufacturing process with clear chemical reactions. Biological drugs, on the other hand, are synthesized under often indeterminate conditions and the precise mechanism of their therapeutic effects is often poorly understood. So, unlike traditional generics, biosimilars are not exact copies of the brand-name drugs they’re based on. There will always be some slight differences.
For most patients, those differences don’t impact the drug’s therapeutic effect. However, for some these structural variations could cause adverse health consequences. The same rules that govern dispensing generic drugs won’t provide sufficient patient safeguards for biosimilars.
This is why the commonsense substitution rules being considered by state leaders make sense. If doctors are promptly and properly informed, they can evolve treatment regimens accordingly if any adverse outcomes arise. It’s all about patient safety.
Biosimilars have enormous potential to improve health and cut costs. The bill now before the Pennsylvania Legislature would establish a basic level of consumer protection without hindering the ability of patients to freely and widely access these drugs. Pennsylvania must pass this critical legislation.
Andrew Spiegel is a co-founder and co-chair of the Global Colon Cancer Alliance (www.global
October 22nd, 2013
ASBM Presents at WHO Meeting on Naming in Geneva
Calls for Distinct Non-Proprietary Names to Ensure Patient Safety
Geneva, Switzerland - The Alliance for Safe Biologic Medicines (ASBM) today presented at the World Health Organization’s (WHO) 57th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. During his presentation, ASBM Chairman, Richard Dolinar, M.D., called for the use of distinct non-propriety names for biologic medicines so that it is clear which medicine or medicines a patient received. Said Dolinar, “It is essential to patient safety that adverse events can be accurately traced back to the correct product. Distinguishable non-proprietary names for biologic medicines make that more likely.”
For nearly three years, ASBM has been dedicated to ensuring that patient safety is at the forefront of biosimilar policy across the globe as regulatory bodies around the world approve biosimilars for use. ASBM has strongly advocated that all biologics be given distinct non-proprietary names to facilitate accurate attribution of adverse events. The non-proprietary name of a reference product and product/s biosimilar to it, should have a common, shared root but have distinct and differentiating suffixes. This will enable regulators to hold manufacturers accountable for the quality of their medicines.
Because biologics are made using living cells, as opposed to traditional chemical drugs, they are highly sensitive to the manufacturing process, storage, handling, etc. and small changes in the medicine can have important implications for patients. ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety.
In his presentation, Dr. Dolinar, a practicing endocrinologist, thanked the WHO for seeking input from the physician and patient communities and urged regulators worldwide to give biosimilars distinguishable names.
“We are grateful for the continued opportunities the WHO has given stakeholders like us to provide input as biosimilar policies are developed,” said Dr. Dolinar. “Product names are a foundational element of communication among health care providers and will have implications for the safe use of biologic medicines. When we speak about drugs, we need to be very specific. If a patient has an adverse reaction, which can occur months after receiving a biologic medicine, we need to be able to properly identify that medication. Instituting a system of distinguishable names will achieve the common goal of enhancing access to these life-changing therapies, while also protecting the safety of the patients.”
In advance of the WHO meeting, ASBM wrote two letters to WHO regarding the need for instituting a system of distinguishable names.
About the Alliance for Safe Biologic Medicines:
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. Visit us at www.SafeBiologics.org.
For more information, please contact:
Alliance for Safe Biologic Medicines