Posts – Page 62 – Safe Biologics

November/December 2013 Newsletter

December 19, 2013

ASBM Releases New European Survey in Dublin

On November 22, ASBM Executive Director Michael Reilly presented preliminary findings of a new survey on European physicians’ views on biosimilar naming at the Drug Information Association (DIA) Biosimilars Workshop in Dublin, Ireland. The key findings showed that nonproprietary names matter to patient safety:

53% of physicians surveyed felt that an identical nonproprietary name implies identical structure – which will not be the case for biosimilar medicines
61% of surveyed physicians said that identical nonproprietary names imply that the medicines are approved for the same indications – which is not necessarily the case
24% of reporting physicians record only the nonproprietary name of the biological product in the patient record

FDA Week Features Story on European Survey

In the FDA Week story “ASBM Uses European Biosimilar Naming Survey To Push Unique Names” Alaina Busch quotes ASBM on the release of the survey:

“‘The consistency of physician perspective in the U.S. and Europe with regard to nonproprietary naming of biologics is striking,” said ASBM Executive Director Michael Reilly, who presented the findings during a Drug Information Association biosimilar workshop in Ireland. ‘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.’

“ASBM, also points out that physicians in Europe have hands-on experience with biosimilars, as opposed to doctors in the United States, where biosimilars have not yet been approved.”‘

Brookings Panel on Biologics

ASBM Chairman Richard Dolinar, MD and Executive Director Michael Reilly participated in the Engelberg Center for Health Care Reform at the Brookings Institution “Developing Systems to Support Pharmacovigilance of Biologic Products” forum on November 15, in Washington, D.C.

Mark B. McClellan, the Director of Health Care Innovation and Value Initiative for Brookings, moderated the panel “Potential Strategies to Identify Biologics for Safety Surveillance.”

Read more here.

Dr. Dolinar Interviewed on WFAS NYC

On November 21, Dr. Dolinar was interviewed on WFAS 1230 talk radio by guest host Seth Ginsberg of the Global Healthy Living Foundation. Dr. Dolinar gave an overview of what biosimilars are and the impact they will have on patients and physicians once they are approved in the U.S. WFAS AM 1230 is broadcast across the greater New York City area and reaches over a million listeners!

Listen to the interview here.

FTC Biosimilars Workshop to be Rescheduled

The FTC canceled the Biosimilars and Interchangeables Workshop on December 10, in Washington, D.C. due to inclement weather. Dr. Dolinar and seven ASBM Members were prepared to attend. The workshop has been rescheduled for February 4, 2014.

The FTC will be accepting public comments through March 1, 2014.

Read more here.

AfPA Working Group on Biologics

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 the presentation here.

Upcoming Conferences

Dr. Dolinar will give the keynote address at the Biosimilars and Follow-On Biologics 2014 Americas conference, which will be in Philadelphia, February 10-12
The CBI 9th Annual Biosimilars Summit will also be held in Philadelphia, March 19-20

ASBM Presents New European Survey Findings on Biosimilars and the Importance of Nonproprietary Naming

November 22, 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:

53% of physicians surveyed felt that an identical nonproprietary name implies identical structure – which will not be the case for biosimilar medicines
61% of surveyed physicians said that identical nonproprietary names imply that the medicines are approved for the same indications – which is not necessarily the case
24% of reporting physicians record only the non-proprietary name of the biological product in the patient record

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:

Michael Reilly

Executive Director

Alliance for Safe Biologic Medicines

Phone: 202-222-8326

E: Michael@safebiologics.org

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

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

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

In the video, Mr. Reilly says:

“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.

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).