Safe Biologics

WHO’s Minutes Reflect INN Consideration of Separate Process for ‘Biologic Qualifiers’ for Biosimilars

As reported in Inside Health Policy’s “WHO Mulls ‘Biological Qualifier,’ Separate from INN, For Biosimilars,” minutes from the meeting held this past October in Geneva reflect the serious examination by World Health Organization to create a system for unique names.

ASBM chairman Richard Dolinar, MD and executive director Michael Reilly, were present at the October meeting. Dolinar gave formal comments during the stakeholder session advocating for a system requiring unique names. However, minutes also reflect that the European Medicines Agency stated, “it was ‘unlikely’ that a biological qualifier would be used in the European Union.”

“The April meeting is going to be really interesting,” state Michael Reilly in the January 31st article, who also noted that “WHO appears to be finding a compromise among the different positions on biosimilar naming.”

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FTC Biosimilars Workshop

On February 4th, the Federal Trade Commission (FTC) held “Follow-On Biosimilars Workshop: Impact of Recent Legislative and Regulatory Naming Proposals on Competition,” in Washington, DC.

The workshop was rescheduled from its original date of December 10th due to inclement weather. The all day workshop focused on a host of issues including the impact state regulations may have on competition; how regulations could be structured to facilitate competition as well as safety; how naming may affect competition, and experiences in other countries. Unfortunately, no patient advocacy groups were scheduled to appear. However, many ASBM partners were in attendance.

The FTC will be accepting public comments through March 1, 2014. ASBM, as well as several other members, intend to submit formal comments.

To view comments from the workshop click here.

To view patient group release and letter to FTC click here.

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States Consider Substitution Legislation Early in 2014

Language introduced in WA and IN may reflect a change to come in biosimilar substitution legislation under debate in several states as some generic companies indicate they will support state proposals.

Washington State

In the Washington State Legislature, biosimilars legislation — HB 2326 and SB 6091– have been introduced. Language in the legislation reflects ASBM principles, including provisions that authorize biosimilars be substituted in place of biologic products if the Food and Drug Administration (FDA) has determined the biosimilar product is interchangeable with the biologic product, and requires the dispensing pharmacist to record the name of the product and the manufacturer in a health records system that is shared with the prescribing provider or communicate it to the prescribing provider directly. It also requires the patient to be made aware of the substitution.

Both the House Health Care & Wellness Committee, and the Senate Health Care Committee have considered the legislation. Currently, the House Health Care & Wellness Committee has HB 2326 scheduled for executive session on February 5th.

To view legislation click here.

Indiana

In Indiana, Senate Bill 262, which is similar to language in WA, has successfully moved out of the Senate Health & Provider Services Committee and was passed out of the full Senate on January 28th by a vote of 38 to 11. The legislation has now moved over to the House where it is hoped to quickly be considered.

To view legislation click here.

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IfPA Publishes Paper on Physician’s Perspective on Biologics

The Institute for Patient Access (IfPA) recently published a paper discussing the need for doctors to be notified of automatic substutions of biosimilar products — a debate currently under consideration in the States.

In the article, Dr. David Charles and Mary Ann Chapman, PhD promote the relationships doctors must maintain with their patients in order to optimize patient care and outcomes. Since biologics are not like chemically synthesized drugs and have large, complex structures difficult to characterize and therefore are not like generics, physicians need to be informed of substitutions that may take place at the pharmacy. Without notification, practitioners may not be able to trace any adverse events or lose critical time properly diagnosing any decline in patient health.

Read IfPA 3-pager here.

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Dr. Dolinar to Give Keynote at Philadelphia Conference

ASBM chairman, Richard Dolinar, MD will give the keynote address at the Biosimilars and Follow-On Biologics 2014 Americas conference in Philadelphia, February 10-12.

The conference will focus on commercial opportunities and regulatory challenges in the biosimilars arena. Dr. Dolinar’s presentation will give a practitioner’s perspective and focus on the need for physician education on biosimilars and the importance of collaboration between physicians and pharmacists to ensure the quality of patient care.

For more details on the conference, click here.

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Upcoming Conferences

The CBI 9th Annual Biosimilars Summit, March 19th-20th – Philadelphia, PA
12 EGA International Biosimilar Medicines Conference, April 3rd-4th -London, UK
Biosimilars and Biobetters USA Conference, April 7th-8th – Iselin, NJ
2014 FDLI Annual Conference, April 23rd -24th, Washington, DC

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

Read more on the survey here.

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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.”‘

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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.

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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.

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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.

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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.

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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

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.

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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.

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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.

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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.

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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.

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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.

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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.