Safe Biologics

ASBM Releases EU Physicians’ Survey in Brussels

On March 18th in Brussels, the Alliance for Safe Biologic Medicines (ASBM) released the results of a survey of 470 European physicians from five countries regarding their prescribing habits and knowledge of biosimilar medicines. Participants in the survey included specialists in the fields of nephrology, rheumatology, dermatology, neurology, endocrinology and oncology. The results were released at a stakeholder roundtable hosted by EuropaBIO, with representatives from physician and patient groups, as well as industry and regulatory bodies.

Key findings showed:

• Only 22% consider themselves as “very familiar” with this new category of medicines…24% “cannot define” or “have not heard about” biosimilars before;
• 53% of those surveyed incorrectly believed that the same International Nonproprietary Name (INN) meant the products were structurally identical;
• 72% of prescribers consider it “critical” or “very important” to decide whether a patient should receive an innovator biologic medicine or a biosimilar; as a consequence…
• 74% consider it “critical” or “very important” that the mention of “dispense as written” on a prescription should be respected; and
• 62% think that it is “not acceptable” for a pharmacist to determine which biologic medicine to dispense at initiation of a treatment.

The findings stressed that using the same INN for two medicines (both the innovator biologic and biosimilar) can be misleading. In addition to implying identical structure (53% of respondents incorrectly thought this to be the case) using the same INN for both medicines may result in false attribution of adverse events if only the INN is reported (as was the case with 17% of physicians surveyed).

The survey was released in advance of the upcoming WHO INN Consultation in Geneva where ASBM will present its findings.

Michael Reilly, executive director, of the ASBM commented: “The ASBM survey is the first large-scale survey on biosimilars in Europe. It reflects the daily clinical practice with regards to biological medicines including biosimilars, and provides facts and figures that put current international, EU as well as national policy developments in the field of naming and substitution into perspective.” – Biosimilar News, March 19th

Nathalie Moll, secretary general of EuropaBIO added, “The results of the survey indicate that the understanding of biosimilars is not yet wide-spread among physicians. At the same time, doctors need to be fully aware of the characteristics of biologics and biosimilars to be in a position to prescribe the medicine that will maximize patient outcomes.” – ThePharmaLetter, March 19th

To view the ASBM survey and presentations, click here.

To view media coverage, check Bloomberg, FirstWord Pharma, BioWorld, PanEuropean Networks, EurActiv and Generics Bulletin.

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58th WHO INN Stakeholder Session Includes ASBM on Agenda

ASBM chairman Richard Dolinar, MD will appear before the World Health Organization (WHO) at its 58th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances meeting to be held April 8th.

The WHO has been considering creating a system of unique names and since the meeting in October has made progress toward compromise amongst the different positions on the naming of biosimilars. Currently, the WHO is contemplating assigning ‘biologic qualifiers’ — a short string of random letters added to the name of a biosimilar — which would allow physicians and pharmacists to distinguish biosimilars from the reference biologic.

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Multi-stakeholder Perspectives Video on Biosimilar Naming

ASBM member Global Healthy Living Foundation (GHLF), recently produced an educational video highlighting the need and importance of unique names for biosimilars. The video includes perspectives from Steve Marmaras of GHLF, Donna Cryer a prominent patient advocate who uses biologics, former FDA official Peter Pitts, as well as ASBM executive director Michael Reilly and RetireSafe president Thair Phillips.

The two-minute video will be hosted on GHLF’s website, healthybiologics.org, and will be circulated through social media.

To view video, click here.

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Indiana Governor Signs Biosimilar Legislation

On March 25th, Governor Mike Pence signed legislation to ensure the safe substitution of interchangeable biologic medicines, approved by the U.S. Food and Drug Administration (FDA).

Senate Bill 262 amends Indiana pharmacy regulations for the treatment of biosimilars by ensuring the proper communication between the pharmacist and the prescribing physician takes place. Specifically the new law provides that the physician must indicate if a substitution is allowable and the pharmacist must notify the treating physician within 10 days of the exact biologic product dispensed by name and manufacturer. The pharmacist is required to retain a written record of the biosimilar substitution for a period of no less than two years. In addition, the pharmacist must also make sure the patient is aware of substitutions that occur.

“This law ensures there are procedures in place to facilitate the exchange of information when biologic medicines are dispensed, while also expanding patient access to biologic medicines,” stated Dr. Dolinar.

ASBM will continue to work with state legislatures in advocating for the necessary substitution guidelines needed to ensure patient safety.

To view ASBM press release, click here.

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Dolinar to Speak at Discovering Cures Illinois Event

Chairman Dr. Richard Dolinar will be part of the Discovering Cures Illinois panel on April 2nd in Springfield. The event will serve as a briefing for state legislators to educate them on biosimilars and will include representatives from Biotechnology Industry Organization (BIO) and Arthritis Foundation – Heartland Region.

Discovering Cures Illinois believes that sound policy in Illinois outlining parameters for safe substitution of interchangeable biologics is the best option to ensure patients have access to high-quality, safe and effective biologic medicines. Discovering Cures core concerns are to ensure transparency and the primacy of the physician-patient relationship, recognizing that treating physicians and their patients are in the best position to determine appropriate therapies.

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FDLI Annual Conference in April

The Food and Drug Law Institute (FDLI) will host their 57th Annual Conference on April 23rd and 24th in Washington, DC.

Breakout session “Interchangeability & Pharmacy Substitution Laws and Regulations in the United States and European Union” will cover compliance and liability issues related to biosimilars. The panel, moderated by John Manthei of Latham & Watkins LLP, will include Michael Reilly of ASBM, Kimberly Greco of Amgen and Christopher Mikson, MD of Jones Day.

For more information on the FDLI conference, click here.

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Upcoming Conferences

April 7th-8th: Biosimilars and Biobetters USA, Iselin, NJ
May 12th: Interfarma, Brazil
June 15th-19th: DIA 50th Annual Meeting, San Diego Convention Center, CA

ASBM Forum Brings Together Leaders on Biosimilars Issues in 2014

On February 25th, the Alliance for Safe Biologic Medicines (ASBM) held a forum to educate patient advocates, physician groups and members of its International Advisory Board on the complex issues related to biosimilars.

The half-day forum entitled, “Ensuring Access to Safe Biosimilars: Policy Developments and Emerging Challenges” focused on the challenges facing world regulators including the U.S. Food and Drug Administration (FDA), the importance of distinguishable nonproprietary names for biosimilars and the value of and need for patient, physician and pharmacist education on issues related to biosimilars.

ASBM Chairman Richard Dolinar, MD kicked off the event with an introduction to biosimilars followed by Executive Director, Michael Reilly highlighting three years of activities ASBM has conducted. Panel discussions, moderated by Brian Rye of Bloomberg Government, included patient advocates Marcia Horn, President of the International Cancer Advocacy Network; Andrew Spiegel, Executive Director of Global Colon Cancer Association; and Joe Jefferson, Director of Advocacy and Alliance Development of HealthHIV. In addition, cancer researcher Dirk Reitsma, MD spoke on the “Regulatory Challenges for the FDA,” and Kirsten Vadheim, PhD discussed “Developing International Regulatory Standards.” The concluding panel covered the development of “A Collaborative Approach to Pharmacovigilance” and featured Dr. Dolinar and Associate Dean Phil Schneider of the University of Arizona’s School of Pharmacy.

To view the full agenda and presentations, click here.

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ASBM Submits Comments to the FTC

The Alliance for Safe Biologic Medicines submitted comments to the Federal Trade Commission (FTC) in regards to the “Follow-On Biosimilars Workshop: Impact of Recent Legislative and Regulatory Naming Proposals on Competition” hearing held in February.

In a letter to FTC Chairwoman Edith Ramirez, ASBM advocates for unique naming of biosimilars as well as physician notification on the state level. These points were discussed at the recent workshop, however, without the voices of patient advocates or practicing physicians.

“When it comes to biosimilars and the contentious issues of proprietary naming and state substitution laws, competitiveness and patient safety need not be mutually exclusive. They are in fact, complimentary.

…we need to be extremely thoughtful about how we set policy relating to these promising medicines and strike a balance that promotes health and safety, rather than forcing a binary response that is driven by profits instead of patients.

If you’re for patient safety, you can’t be against distinguishable naming.”

ASBM also addressed arguments made at the FTC meeting that physician notification was anti-competitive because it somehow undermines the reputation of biosimilars and indicates that they are somehow of poor quality.

ASBM replies, what they don’t “seem to understand is that interchangeable biologics are different from their innovator progenitors – but bioequivalent enough to be therapeutically interchangeable (as per the FDA). That’s not a ‘scare tactic,’ that’s just a fact.”

To read full comments to the FTC click here.

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Indiana Substitution Legislation Headed to Governor

In Indiana, Senate Bill 262, has successfully moved through both chambers of the legislature with a strong vote of 92-5 in the State House. The legislation will now move to Governor Pence where it is hoped to quickly be considered.

ASBM has written Governor Pence in strong support of the enactment of this legislation stating, “We believe that when interchangeable biosimilar products are substituted, communication among patients, pharmacists, and health care providers is essential to patient care and, therefore, we fully support SB 262 and are concerned that patient safety will be compromised if this legislation is not enacted.”

To view legislation click here.

To view ASBM letter to Governor Pence click here.

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Chairman Dolinar, Continued Authority on Physicians’ Perspectives of Biosimilars

ASBM Chairman Richard Dolinar, MD will be retuning to Philadelphia for the 9th Annual Biosimilars Summit, hosted by CBI on March 20th.

This year’s Biosimilars Summit will address regulatory challenges involving biosimilars and also state legislation related to physician notification when biosimilars are substituted for prescribed biologics. Dolinar’s presentation entitled, “Keeping Physicians Informed about Biosimilar Utilization” will focus on the difference between biosimilars and generic drugs as well as educating physicians about interchangeability and pharmacovigilance.

For more details on the conference, click here.

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ASBM Scheduled to Participate in WHO 58th INN Consultation

ASBM Chairman Richard Dolinar, MD is once again on the docket to present comments before the World Health Organization (WHO) at its 58th Consultation on International Nonproprietary Names for Pharmaceutical Substances meeting to be held April 8th-10th.

The WHO has been considering creating a system of unique names and has recently made progress toward compromise amongst the different positions on the naming of biosimilars. Recent reports state that the WHO may consider assigning ‘biologic qualifiers’ — a short string of random letters added to the name of a biosimilar which would allow physicians and pharmacists to distinguish it from its reference biologic.

ASBM will present findings of its recent survey on European physicians’ views on biosimilar naming, which will officially be released on March 18th in Brussels.

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Reilly Set to Address U.S. and International Biosimilars Regulations at FDLI Conference

On April 23rd-24th, the Food and Drug Law Institute will host their 57th Annual Conference in Washington, DC.

ASBM Executive Director Michael Reilly will appear in a breakout session on compliance and liability issues related to biosimilars. The panel, entitled “Interchangeability & Pharmacy Substitution Laws and Regulations in the United States and European Union”, will be moderated by John Manthei of Latham & Watkins LLP and also feature Kimberly Greco of Amgen and Christopher Mikson, MD of Jones Day.

For more information on the FDLI conference, click here.

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