Dr. Dolinar on WFAS AM Talk Radio
November 21, 2013
Dr. Dolinar discusses biosimilars with Seth Ginsberg of the Global Healthy Living Foundation on WFAS AM 1230 talk radio, Greater NYC. Listen here.
Dr. Dolinar Keynote at AfPA Working Group on Biologics, Chicago
November 15, 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.
October 2013 Newsletter
November 14, 2013
FTC to Host Workshop on Biosimilars
The Federal Trade Commission (FTC) will be holding a public workshop on December 10, 2013 in D.C. to discuss competition issues surrounding biologics and biosimilars. The workshop will specifically focus on how state regulations and naming conventions may impact the development of, and competition for, biosimilars.
The FTC will be accepting public comments through March 1, 2014.
Read more here.
ASBM Presents at WHO Meeting on Naming in Geneva
On October 22, ASBM 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 nonproprietary names for biologic medicines so that it is clear which medicine or medicines a patient received.
Dolinar said, “It is essential to patient safety that adverse events can be accurately traced back to the correct product. Distinguishable nonproprietary names for biologic medicines make that more likely.”
Read more here.
ASBM Executive Director Quoted in FDA Week
A group of six senators recently wrote a letter to the FDA saying that the agency would violate Congressional intent if the FDA decided that biosimilars cannot share the same name as their reference product.
In the October 31 FDA Week article, “BIO Disagrees With Lawmakers, Says ACA Left Biosimilar Naming To FDA” Michael Reilly explained that ASBM disagrees with the senators’ letter because Congress left naming to the discretion of the FDA.
“[T]he section of the Affordable Care Act that created the biosimilar pathway was written broadly to give FDA discretion. Further, he said the lawmakers’ letter relies on access issues to make the argument in favor of shared names, therefore it ‘does not hit at the heart of what FDA’s job is,’ he said.
“‘We’re a long way from that letter turning into anything that could interfere with the FDA,’ he said.
“ASBM was among the stakeholders that testified during the WHO’s 57th Consultation on International Nonproprietary Names for Pharmaceutical Substances in Geneva, Switzerland last week. At the meeting, the Generic Pharmaceutical Association pressed for biosimilars to have the same INN as the reference product. Meanwhile ASBM, whose representation includes patient groups, professional organizations and drug companies, asserted that unique names are necessary to track any safety problems that arise.
“Reilly said he got a sense during the meeting’s open session that WHO will act — possibly before the next consultation in April.”
Read the full story here.
Globe & Mail Video Series on Biosimilars
Michael Reilly is featured in a new Globe & Mail video series on biosimilars. Globe & Mail is the national newspaper for Canada and in his video, Reilly provides a global perspective on biosimilars, with a focus on why manufacturing matters. This new online series was created to provide viewers with easy to watch videos on the future of biosimilars.
View the video here.
Stateside: Biosimilars Legislative Updates
Indiana
On October 22, Andrew Spiegel, Executive Director of the Global Colon Cancer Association, testified before the Indiana Health Finance Commission in support of biosimilar legislation under consideration.
Read his testimony here.
Pennsylvania
Andrew Spiegel also had an Op-Ed featured in the Pittsburgh Post-Gazette. In Allow ‘biosimilars’ in Pennsylvania he said:
“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.”
Read the full piece here.
NALEO Latino Legislative Summit on Health
On October 26, Dr. 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.
Read more here.
Upcoming Conferences
- Engelberg Center for Health Care Reform at the Brookings Institution “Developing Systems to Support Pharmacovigilance of Biologic Products” November 15 in Washington, D.C.
- Alliance for Patient Access National Physicians Biologics Working Group Meeting, November 15-16 in Chicago, IL.
- DIA Biosimilars Workshop, November 21-22 in Dublin, Ireland.
ASBM Quoted in FDA Week
November 7, 2013
InsideHealthPolicy’s FDA Week an exclusive weekly report on Food and Drug Administration policy, regulation and enforcement
From Vol. 19, No. 44, November 1, 2013 BIO Disagrees With Lawmakers, Says ACA Left Biosimilar Naming To FDA
The innovator biologics industry disagrees with a bipartisan group of senators’ view that FDA would violate congressional intent if it were to decide biosimilars can’t share the same name as their reference products, arguing that the health care law left biosimilar naming decisions up to FDA’s discretion. The issue has been hotly debated among stake- holders in the weeks leading up to a recent World Health Organization meeting where one attendee said WHO signaled it would adopt a position.
The innovator and generic drug industries have voiced differing views on whether biosimilars should share an International Nonproprietary Name with the reference product or have a different identifier, possibly including a prefix or suffix. Last week a bipartisan group of six senators weighed in on the side of generics, writing to FDA that the agency would violate congressional intent were it to decide that biosimilars cannot share the same name as their reference product.
The lawmakers said requiring different names would raise safety and economic concerns, and pointed out that lawmakers rejected a statutory requirement that biosimilars be given unique names when they debated the Affordable Care Act. Lawmakers signing onto the letter included: Sens. Tom Harkin (D-IA), who chairs the Senate health committee, Jay Rockefeller (D-WV), John McCain (R-AZ), Bill Nelson (D-FL), Charles Schumer (D-NY) and Ron Wyden (D-OR).
The Biotechnology Industry Organization on Monday (Oct. 28) countered the lawmakers’ argument, saying Congress left naming decisions in the hands of FDA experts.
“Congress left it to the experts at FDA to make the decision about product names – as the agency does for every other product,” BIO said, responding to the lawmakers’ letter. “Reserving this to FDA will allow for thorough consider- ation of technical, scientific and patient safety issues involved. Minor differences between innovator and biosimilar products could lead to real differences for patients, therefore it would be inappropriate to permit use of the same nonpro- prietary name for biological products that are not the same from a regulatory or scientific perspective.”
Michael Reilly, executive director of the Alliance for Safe Biologic Medicines, agreed, saying the section of the Affordable Care Act that created the biosimilar pathway was written broadly to give FDA discretion. Further, he said the lawmakers’ letter relies on access issues to make the argument in favor of shared names, therefore it “does not hit at the heart of what FDA’s job is,” he said.
“We’re a long way from that letter turning into anything that could interfere with the FDA,” he said.
ASBM was among the stakeholders that testified during the WHO’s 57th Consultation on International Nonproprietary Names for Pharmaceutical Substances in Geneva, Switzerland last week. At the meeting, the Generic Pharmaceutical Association pressed for biosimilars to have the same INN as the reference product. Meanwhile ABSM, whose representa- tion includes patient groups, professional organizations and drug companies, asserted that unique names are necessary to track any safety problems that arise.
Reilly said he got a sense during the meeting’s open session that WHO will act — possibly before the next consulta- tion in April.
“The chairman (of the INN expert group) kind of concluded by saying, ‘We have our work to do,'” he said. Reilly noted the chairman also conveyed that not everyone would be happy with the outcome, although there is awareness of where everyone agrees and disagrees.
The issue has stirred debate among the innovator and generic drug industries, patient advocates and pharmacists. Three pharmacy groups last week reiterated their view that National Drug Codes are an alternative way to identify specific products, and said assigning unique names could interfere with pharmacy safety systems and complicate the collection of global safety information.
The National Kidney Foundation this week weighed into the debate on the side of innovators.
In a letter to FDA, the group states: “Tracking through NDC codes will not capture all cases because payers do not universally use NDC codes and these codes are not necessarily found in patient records,” according to the foundation’s Monday (Oct. 28) letter. “We recognize that the FDA is working diligently on an approval pathway that will ensure that biosimilars are both safe and effective, but our concern is that since biosimilars are produced without access to the innovator’s proprietary manufacturing processes, differences in composition compared to the original innovator product are likely to occur even for those considered interchangeable. While these changes may be minute, we know that individual patients can respond differently to even seemingly insignificant changes in drug formulation, manufacturing process, packaging, storage, or handling.”
Kerry Willis, the foundation’s senior vice president of scientific activities, said the group’s letter was a reminder to the agency of where the foundation stands. She pointed to previous safety issues that emerged soon after biologics launched or because of manufacturing changes as reason for being able to quickly find the source of adverse events.
In terms of patient access to lower cost medications, she said doctors will likely continue prescribing the lower cost options, even if this requires looking up names. “I think that doctors are aware of the cost issues,” she said. — Alaina Busch
Copyright 2013 Inside Washington Publishers. Reprinted with permission.
Read the full article here.
Dr. Dolinar Addresses State Legislators at NALEO Summit on Health
November 6, 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.
ASBM Executive Director Featured in Globe & Mail Video Series on Biosimilars
October 28, 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.
ASBM Executive Director Featured in Globe & Mail Video Series on Biosimilars
October 28, 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.
Andrew Spiegel Op-Ed Featured in Pittsburgh Post-Gazette
October 28, 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
cca.org).
ASBM Presents at WHO Meeting on Naming in Geneva
October 22, 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:
Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326
E: Michael@safebiologics.org
ASBM Presents at WHO Meeting on Naming in Geneva
October 22, 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:
Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326
E: Michael@safebiologics.org
