ASBM Submits Comments on FDA Interchangeability Guidance

May 19, 2017

On May 19th, ASBM submitted comments on the FDA’s Draft Guidance Considerations in Demonstrating Interchangeability With a Reference Product. The comments may be read in their entirety below, or are available here as a PDF.

 

May 22, 2017

 

Division of Dockets Management (HFA-305)here.

Food and Drug Administration Department of Health and Human Services

5630 Fishers Lane, Room 1061

Rockville, MD 20852

 

Re: Docket Number FDA-2017-D-0154

Considerations in Demonstrating Interchangeability With a Reference Product;
Guidance for Industry, Draft Guidance

 

Dear Sir or Madam,

The Alliance for Safe Biologic Medicines (ASBM) respectfully submits the following comments in response to the recent draft guidance on Considerations in Demonstrating Interchangeability With a Reference Product, published to the Federal Register on January 18, 2017.

ASBM is an organization focused on promoting the increased availability and use of biologic medicines, while ensuring their safety and efficacy. It is our mission to serve as an authoritative resource of information for the general public as well as the healthcare and health policy communities on issues surrounding biologic medications. We provide information on the development, regulation, safety, and quality of biologics, advocate for policies that prioritize medical decisions between patients and physicians, and seek solutions that ensure affordability and accessibility of biologic medications, while never compromising patient safety.

We are both closely affiliated with ASBM: I (Harry Gewanter) am a pediatric rheumatologist practicing in Richmond, VA and ASBM’s Chairman; Philip Schneider is Clinical Professor and Associate Dean for Academic and Professional Affairs for the University of Arizona, College of Pharmacy and Chairman of ASBM’s Advisory Board.

ASBM appreciates the science-based approach that FDA has demonstrated to date in considering biosimilar policy. ASBM applauds FDA for the successful implementation of policies that allow safe and effective biosimilars to come to market, thereby increasing treatment options and broadening access to life changing medications for patients with serious grievous illnesses.

Biologic interchangeability is complex, but it is critically important to maintain patient safety, and ASBM commends FDA for the comprehensive, thoughtful methodology they have applied in developing this draft interchangeability guidance. ASBM agrees with all elements outlined in the draft guidance and suggests adding the following points for consideration.

  1. General Principles

We agree with FDA’s recommendation that a sponsor seek licensure for a proposed interchangeable product for all of the reference products licensed conditions of use[1]. We recommend that the FDA strengthen this position to require sponsors to only seek an interchangeability designation if they can provide evidence to support interchangeability for all of the licensed conditions of use. If they cannot, we recommend that the product is instead approved as a biosimilar and NOT an interchangeable biosimilar.

As practicing clinicians, we are familiar with the day-to-day aspects of treating patients with biologics. The clinical reality is that if a biologic is approved as interchangeable for one indication, it will be assumed that it is interchangeable for all conditions of use, regardless of whether the agency has considered sufficient supporting evidence. This assumption is hard-wired into clinician behavior as a result of decades of experience with generic medicines, where therapeutic equivalence, once demonstrated, applies across all indications. This approach is not appropriate for biologic medicines and has the potential to lead to inappropriate substitution that can put patient safety at risk. ASBM asks FDA to ensure that approval decisions related to interchangeability are limited to those supported by scientific evidence, which can include sound scientific justification for appropriate extrapolation.

Similarly, ASBM requests clarification on the Agency’s plans should subsequent data emerge suggesting a detrimental impact associated with switching in one or more conditions of use. While it is evident that this would need to be handled on a case-by-case basis, we believe it important to create a process by which an interchangeability designation can be retracted. This retraction should be accompanied by a widespread communication strategy to ensure clinicians using these medicines are aware of the change in status so that they can adapt their clinical practice accordingly.

 

  1. Factors Impacting the Type and Amount of Data and Information Needed to Support a Demonstration of Interchangeability

ASBM supports FDA’s ‘totality of evidence’ approach applied to the approval of biosimilar and interchangeable biosimilar medicines. ASBM believes that, while critically important to the totality of evidence paradigm, the use of analytical data should always be associated with clinical studies that provide sufficient evidence that switching between biologic products does not result in an increased risk to patients in terms of safety or diminished efficacy.

The role of real-world data in evaluating long-term safety and efficacy of medicines is unparalleled. Specific to biosimilars, real-world evidence has the potential to provide a wealth of important information on the effects of switching between biologics of the same product class. ASBM does however support FDA’s statement that “….postmarketing data collected from products first licensed and marketed as a biosimilar, without corresponding data derived from an appropriately designed, prospective, controlled switching study or studies, generally would not be sufficient to support a demonstration of interchangeability.” [2] While postmarketing data are important for evaluating real-world safety and efficacy, it is unlikely they will provide either the critically important pharmacokinetic or pharmacodynamic data required to fully evaluate the impact of switching. For example, comparing neutralizing antibody and drug trough levels among patients who have either been switched or not switched, is a critical element in evaluating whether the switch has resulted in an increased risk to the patient in terms of safety or diminished efficacy. ASBM believes that when evidence is needed to support an interchangeability designation, real-world evidence should not be used as a substitute for a randomized clinical study.

ASBM supports FDA’s recommendation that any population selected for study is sufficiently sensitive to detect differences between the switched and non-switched arms.[3] An important indicator of decreased efficacy or increased risk associated with a switch is the elevation of neutralizing antibodies and their effect on drug trough levels. Detection of this type of response is dependent on a patient’s ability to mount an immune response. Since many patients treated with these biologic medicines are immunocompromised as a result of their disease and/or treatment, those patients are not the ideal population to evaluate in a switching study.

  • Use of a US-licensed Reference Product in a Switching Study or Studies

ASBM supports FDA’s positon that while a non-US comparator is appropriate for a demonstration of biosimilarity, this would NOT be appropriate in a study designed to evaluate the impact of switching[4]. As FDA points out, the purpose of a switching study is to evaluate whether one product will affect the immune system’s response to the other product once the switch occurs and what impact this has on the patient. In clinical practice, patients treated with a licensed biologic product approved in the US will be switched to a US-licensed interchangeable biosimilar. The only appropriate way to investigate the effects of a switch and to confidently designate a biosimilar as interchangeable is to mirror clinical practice and use US-licensed products.

ASBM agrees that because of the possibility of subtle differences between the US-licensed product and the non-US licensed product, evaluating the effects of the switch using a non-US licensed product is inappropriate.

  1. Considerations for Developing Presentations for Proposed Interchangeable Products

ASBM supports FDA’s recommendations regarding product presentations for interchangeable products and would like to commend FDA for its in-depth guidance on this topic. To minimize confusion among clinicians, ASBM believes it important that an interchangeability designation is sought for all presentations (e.g. pre-filled syringe, vial, device) for which the biosimilar product is marketed. In day-to-day clinical practice, it would be almost impossible to prescribe and dispense the appropriate biologic medicine if, for example, the prefilled syringe was licensed as an interchangeable biosimilar and the vial was licensed as a biosimilar (but not interchangeable). While this scenario seems unlikely, we believe it important that the final interchangeability guidance explicitly state that the sponsor seek an interchangeability designation for all the presentations which will be available to clinicians. If this is not possible, ASBM believes there should be a clear notification placed either on the vial or pre-filled syringe directly, or on the packaging, or both, indicating whether or not the presentation is a biosimilar, or an interchangeable biosimilar.

 

  1. Addressing the questions outlined in the Federal Register

 

  1. With respect to interchangeable products, are there considerations in addition to comparability assessments that FDA should consider in regulating post-approval manufacturing changes of interchangeable products?

It is ASBM’s opinion, that, once approved, manufacturing changes for either the reference product or the interchangeable product should be addressed independently and managed by the Agency’s existing process for manufacturing changes.

 

  1. FDA expects that sponsors seeking an interchangeability determination will submit data and information to support a showing that the proposed interchangeable product can be expected to produce the same clinical result as the reference product in all of the reference product’s licensed conditions of use. How, if at all, should the Agency consider conditions of use that are licensed for the reference product after an interchangeable product has been licensed?

As outlined in the sections above, it is ASBM’s view that a biosimilar can only be deemed interchangeable if there is sufficient evidence to support safe switching in each of the conditions of use licensed for the reference product. This applies both at the time of initial licensure, and for additional conditions of use licensed the reference product after the interchangeable biosimilar has been licensed. This opinion is based on how interchangeable products will likely be used in real-world clinical practice. That is, if a product is deemed interchangeable, clinicians will assume it is interchangeable for all the indications for which the reference product is licensed.

In the draft interchangeability guidance, FDA suggests that data used to support a determination of interchangeability can be extrapolated to support additional conditions of use, provided there is scientific justification. One possible way to address additional indications sought for the reference product after initial approval of the interchangeable biosimilar is to apply this approach; specifically, to require the biosimilar sponsor to provide scientific justification to support extrapolation to the new indication licensed for the reference product.

If the scientific justification is deemed inadequate by the Agency however, ASBM recommends that the interchangeability designation is reconsidered to protect patient safety. It is also important that both the reference product and the interchangeable biosimilar receive approval for the new indication in the same timeframe. This could likely be achieved by setting a time limit for the sponsor of the interchangeable biosimilar to submit evidence to support the new indication and/or ensuring that the new indication sought by the sponsor of the reference product is not approved until the sponsor of the interchangeable biosimilar submits evidence.

 

  1. Interchangeability: naming and labeling

Finally, ASBM would like to take this opportunity to reiterate previous comments submitted to FDA on biosimilar naming and labeling, as they relate to interchangeability.

As FDA finalizes the draft guidance on Labeling for Biosimilar Products Guidance for Industry, published to the Federal Register on April 4, 2016, ASBM urges the Agency to include a statement of interchangeability in the product label of interchangeable biosimilars.

FDA has long recognized the immunogenic potential of biologic medicines and the possibility of unwanted immune reactions that may occur as a result of switching between two similar, but not identical, biologics. For healthcare practitioners to be able to quickly and easily grasp how these medicines should be used clinically, a clear statement in the label indicating either biosimilarity or interchangeability is critical. This will ensure the patient and all healthcare practitioners, from the prescribing physician to the dispensing pharmacist, will understand whether or not a given medication can be safely switched. Clear definitions of ‘biosimilar medicine’ and ‘interchangeable biosimilar medicine’ will help ensure that patients receive these medicines appropriately. Importantly, 79% to 88% of physicians and pharmacists consider a statement of interchangeability in a biosimilar product label important or very important.[5]

ASBM also believes it is important to make it clear in the final interchangeability guidance and the product label that the interchangeability designation only applies to an interchangeable biosimilar and the reference product. The switching studies supporting an interchangeability designation will likely evaluate the effects of switching between the interchangeable biosimilar and the reference product. They will not evaluate the effects of switching between the reference product and more than one interchangeable biosimilar, or between interchangeable biosimilars, both of which are potential clinical scenarios. As more interchangeable biosimilars come to market, it is important that clinicians have a clear understanding of what the interchangeability designation means to facilitate evidence-based clinical decision-making.

Further, we believe it is important that the data used to demonstrate interchangeability are included in the product label. It is ASBM’s view that including these data will create increased trust among physicians prescribing these medications and foster clinician and patient confidence in their use, thereby increasing uptake.

ASBM supports FDA’s guidance on nonproprietary naming for biosimilars as it pertains to the use of distinguishable suffixes added to the end of a shared root name, as outlined in the recent guidance.[6] We ask that FDA ensures that this guidance is also applied to interchangeable biosimilars. Further, we would like to take this opportunity to ask that the FDA re-consider the use of random suffixes. ASBM believes that memorable suffixes related to the name of the biologic manufacturer will minimize confusion while enabling a connection to the biologic manufacturer, facilitating traceability and accountability. This view is supported by members of the healthcare community who use these products. In 2015, ASBM conducted a survey of 400 US prescribers of biologics and found that 66% supported FDA issuing distinct names for all biologics, including biosimilars. Sixty percent of respondents preferred suffixes based on the manufacturer’s name. Similarly, among 401 US pharmacists surveyed in October 2015, 68% supported FDA issuing distinct names, with 77% supporting manufacturer-based suffixes. It is ASBM’s view that the introduction of interchangeable biosimilars, and the resulting clinical environment where patients can be switched back and forth between biologic medicines of the same class, creates a need for robust pharmacovigilance. This could be more efficiently facilitated by the use of meaningful suffixes related to the manufacturer of the biologic medicine.

 

In Summary

ASBM thanks the FDA for applying such a rigorous and scientifically robust approach to the complicated topic of interchangeability. The availability of biosimilars in the US represents an opportunity for many more patients to gain access to these lifesaving medicines, but clinician confidence is critical to their success. Knowing the FDA is applying robust, evidence-based principles to the licensure of interchangeable biosimilars will bolster clinician and patient comfort with this important class of medications.

As this draft interchangeability guidance is finalized, ASBM encourages FDA to consider the points outlined in this document, as we believe they are in the best interests of patient safety.

ASBM thanks you for the opportunity to weigh in on these important issues.

 

Sincerely,

Harry L. Gewanter, M.D., FAAP, FACR
Chairman
The Alliance for Safe Biologic Medicine

 

Philip Schneider, MS, FASHP
Advisory Board Chairman
The Alliance for Safe Biologic Medicines

 

 

ASBM Steering Committee Members:

Alliance for Patient Access

American Academy of Dermatology

American Autoimmune Related Diseases Association (AARDA)

Association of Clinical Research Organizations

Colon Cancer Alliance

Global Colon Cancer Association

Global Healthy Living Foundation

Health HIV

Hepatitis Foundation International

International Cancer Advocacy Network

Kidney Cancer Association

National Psoriasis Foundation

ZeroCancer

 

[1] Considerations in Demonstrating Interchangeability With a Reference Product; Guidance for Industry, Draft Guidance. Page 4, lines 116-119

[2] Considerations in Demonstrating Interchangeability With a Reference Product; Guidance for Industry, Draft Guidance. Page 8, lines 270-273

[3] Considerations in Demonstrating Interchangeability With a Reference Product; Guidance for Industry, Draft Guidance Page 13, lines 473-475

[4] Considerations in Demonstrating Interchangeability With a Reference Product; Guidance for Industry, Draft Guidance, Page 15, lines 578-579

[5] ASBM survey data; 2015. Available at https://safebiologics.org/surveys/

[6] Non-proprietary naming for biological products, available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM459987.pdf

 

 

 

 


ASBM Exhibits at Digestive Disease Week 2017

May 12, 2017

ASBM's booth at the Digestive Disease Week 2017 Conference.
ASBM’s booth at the Digestive Disease Week 2017 Conference.

May 6th-9th, ASBM exhibited at Digestive Disease Week (DDW) 2017, an annual gathering of gastroenterologists, patient advocates, and drug manufacturers held in Chicago, IL. ASBM Steering Committee member Andrew Spiegel, Executive Director of Global Colon Cancer Association (GCCA), represented ASBM and GCCA in a booth shared by both groups.

Mr. Spiegel discussed the importance of biologic medicines with many attendees, and emphasized the need to build patient and physician confidence in biosimilars through data and transparency. ASBM member Colon Cancer Alliance also exhibited. 


ASBM Exhibits at Digestive Disease Week 2017

May 12, 2017

ASBM's booth at the Digestive Disease Week 2017 Conference.
ASBM’s booth at the Digestive Disease Week 2017 Conference.

May 6th-9th, ASBM exhibited at Digestive Disease Week (DDW) 2017, an annual gathering of gastroenterologists, patient advocates, and drug manufacturers held in Chicago, IL. ASBM Steering Committee member Andrew Spiegel, Executive Director of Global Colon Cancer Association (GCCA), represented ASBM and GCCA in a booth shared by both groups.

Mr. Spiegel discussed the importance of biologic medicines with many attendees, and emphasized the need to build patient and physician confidence in biosimilars through data and transparency. ASBM member Colon Cancer Alliance also exhibited. 


VIDEO: Pharmacists and Biosimilars

May 4, 2017

In this video, ASBM’s Advisory Board Chairman Philip Schneider, Associate Dean of the University of Arizona College of Pharmacy; and Advisory Board Member Ronald Jordan, Dean of the Chapman University School of Pharmacy discuss the role of pharmacists with respect to biosimilars.

 

 


FDA Approves Fifth Biosimilar

May 2, 2017

On Friday, April 21st, the FDA approved its fifth biosimilar, Renflixis (infliximab-abda). While the second biosimilar approved for Remicade (infliximab)- the first being Inflectra (infliximab-dyyb), approved in April 2016. Renflexis is noteable as the first biosimilar to be approved without a meeting of an FDA Advisory Committee.

Advisory committees provide FDA with independent opinions and recommendations from outside experts on applications to market new drugs, and on FDA policies.  The marketing applications include data to show the safety and effectiveness of human drugs.  The outside experts receive summary information about the applications and copies of  FDA’s review of the application documents.  Based on this information, advisory committees may recommend approval or disapproval of a drug’s marketing application.  FDA generally follows an advisory committee’s recommendation, but is not bound to do so.

Renflixis (infliximab-abda) is also the first biosimilar approved after the finalization of the FDA’s Naming Guidance in January 2017.

Read more about Renflixis (infliximab-abda) here.

 


ASBM Presents at WHO 64th Naming Meeting

April 5, 2017

On April 4rd, in Geneva, Switzerland, ASBM participated in the World Health Organization’s 64rd Stakeholder Consultation on International Nonproprietary Names. ASBM has been a regular participant at the INN Consultations since 2013. ASBM’s Chairman Harry L. Gewanter, Advisory Board Chair Philip Schneider, MS, FASHP and Advisory Board Member Jeff Jones, PhD represented ASBM at this meeting.

The subject of the INN meeting is the continued development and implementation of the INN Programme’s Biologic Qualifier (BQ) proposal. The is a modification to the INN system designed to ensure clear product identification between biosimilars and their reference product by means of a four-letter distinguishing suffix appended to a common root name.

The Executive Summary from the 64nd INN Consultation may be viewed here.


ASBM Chair Testifies in Support of KS Biosimilar Bill

March 17, 2017

gewanterks-small

On March 16th, ASBM Chairman Harry Gewanter, MD testified before the Kansas Senate Public Health and Welfare Committee in support of HB 2107 which would modify the Kansas Pharmacy Act to permit the pharmacy-level substitution of interchangeable biosimilars. ASBM’s Advisory Board Chair Philip Schneider, Associate Dean of University of Arizona College of Pharmacy testified in support of HB 2107 before the House Health and Human Services Committee on January 24th.

HB 2107 would allow Kansas pharmacists to substitute interchangeable biosimilars in place of their reference products, provided that the physician is allowed to prevent a substitution they consider medically inappropriate for the patient by writing “Dispense as Written” or similar language on the prescription. HB 2107 also requires that the pharmacist inform the patient of the substitution at the time the biosimilar is dispensed, and communicate to the physician within 5 business days that a substitution has occurred. Similar legislation has been enacted in 28 states and Puerto Rico over the past several years.

 

gewanter-ks
Committee Chair Sen. Vicki Schmidt (right), a pharmacist, listens as Dr. Gewanter explains the importance of collaboration and communication between healthcare providers when biosimilar substitution is a possibility.

Said Dr. Gewanter in his testimony:

HB 2107’s language reflects the opinions of the majority of biologic prescribing physicians throughout the United States. In surveys conducted by ASBM of 376 US physicians, over 4 out of 5 considered communication in the event of a biosimilar substitution as well as the authority to prevent a substitution by indicating ‘dispense as written’ on a prescription, ‘very important’ or ‘critical’. As noted in the supplemental information from the Kansas House Committee on Health and Human Services, the language in this bill is also supported by a number of patient and physician groups, pharmaceutical manufacturers and a national specialty pharmacy company

It is our view that HB 2107 appropriately reflects the importance of patient-pharmacist- physician communication and collaboration when biosimilar substitution is a possibility. Further, it maintains the patient-physician relationship and decision-making at the core of these important treatment decisions while also not placing an undue or onerous burden upon the pharmacist.


ASBM Chair Testifies in Support of KS Biosimilar Bill

March 17, 2017

gewanterks-small

On March 16th, ASBM Chairman Harry Gewanter, MD testified before the Kansas Senate Public Health and Welfare Committee in support of HB 2107 which would modify the Kansas Pharmacy Act to permit the pharmacy-level substitution of interchangeable biosimilars. ASBM’s Advisory Board Chair Philip Schneider, Associate Dean of University of Arizona College of Pharmacy testified in support of HB 2107 before the House Health and Human Services Committee on January 24th.

HB 2107 would allow Kansas pharmacists to substitute interchangeable biosimilars in place of their reference products, provided that the physician is allowed to prevent a substitution they consider medically inappropriate for the patient by writing “Dispense as Written” or similar language on the prescription. HB 2107 also requires that the pharmacist inform the patient of the substitution at the time the biosimilar is dispensed, and communicate to the physician within 5 business days that a substitution has occurred. Similar legislation has been enacted in 28 states and Puerto Rico over the past several years.

 

gewanter-ks
Committee Chair Sen. Vicki Schmidt (right), a pharmacist, listens as Dr. Gewanter explains the importance of collaboration and communication between healthcare providers when biosimilar substitution is a possibility.

Said Dr. Gewanter in his testimony:

HB 2107’s language reflects the opinions of the majority of biologic prescribing physicians throughout the United States. In surveys conducted by ASBM of 376 US physicians, over 4 out of 5 considered communication in the event of a biosimilar substitution as well as the authority to prevent a substitution by indicating ‘dispense as written’ on a prescription, ‘very important’ or ‘critical’. As noted in the supplemental information from the Kansas House Committee on Health and Human Services, the language in this bill is also supported by a number of patient and physician groups, pharmaceutical manufacturers and a national specialty pharmacy company

It is our view that HB 2107 appropriately reflects the importance of patient-pharmacist- physician communication and collaboration when biosimilar substitution is a possibility. Further, it maintains the patient-physician relationship and decision-making at the core of these important treatment decisions while also not placing an undue or onerous burden upon the pharmacist.


March 2017 Newsletter

March 5, 2017

 

newsletter | March 2017  
issue 56  

Who We Are

The Alliance for Safe Biologic Medicines is an organization composed of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, and others who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of ASBM to serve as an authoritative resource center for policy makers, the healthcare community and the general public on the issues surrounding biologic medications around the globe. 

Our Perspective

Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Therefore, ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety. We advocate, internationally as well as in the U.S., for policies that keep medical decisions between patients and physicians; seek solutions that ensure affordability and accessibility of biologic medicines; and avoid confusion while never compromising on patient safety.

For media inquiries please contact: michael@safebiologics.org
Alliance for Safe Biologic Medicines
PO Box 3691
Arlington, VA 22203
(703) 971 – 1700
Follow Us

Twitter: @SafeBiologics

Facebook

LinkedIn 

YouTube 

ASBM Submits Expression of Interest to participate in WHO Naming Meeting

On February 24th, ASBM submitted an Expression of Interest (EOI) to participate in the Open Session for Stakeholders at the 64th Consultation on International Nonproprietary Names, to be held April 4th, 2017. 

ASBM has been a regular participant at the INN Consultations since 2012, sharing the perspectives of healthcare providers regarding biologic naming with the INN Expert Group as it works to implement its naming proposal, known as the Biological Qualifier (BQ).

ASBM Advisory Board Chair Testifies in Support of NM Substitution Bills

On February 20th, ASBM Advisory Board Chair Philip Schneider, Associate Dean of University Arizona College of Pharmacy, testified before the New Mexico Legislature in support of its biosimilar substitution bill. Dr. Schneider appeared before the House Business and Industry Committee to support HB 260, and the Senate Corporations and Transportation Committee to support SB 180; both bills contain identical language.

From Dr. Schneider’s testimony:

“Current New Mexico law has no clear pathway for substitution of biosimilar drug products. [HB 260 and SB 180] will establish a clear substitution process by allowing pharmacists to dispense an FDA approved interchangeable biologic without first seeking approval…It will increase access to new treatment options and lower cost medicines for patients, without posing an undue burden on pharmacists. 27 states have passed similar legislation in the past few years.”

Both bills subsequently passed unanimously out of their respective committees.

ASBM Steering Committee Member Briefs Alabama Legislators

On February 16th, ASBM Steering Committee Member Andrew Spiegel, executive director of the Global Colon Cancer Association, represented ASBM at a briefing for Alabama lawmakers.

The lunch briefing, entitled “the Power of Biologics and Biosimilars: Revolutionizing Treatment for Patients with Serious Illnesses” featured Mr. Spiegel, who spoke of the great enthusiasm regarding biosimilars among the patient community. “Biosimilars will bring patients new treatment options at reduced cost”, Mr. Spiegel explained, “but physicians and pharmacists must work collaboratively and communicate with one another to ensure their safe use.”

Mr. Spiegel was joined at the briefing by an industry representative who outlined the science of biologics and biosimilars, and the sponsor of Alabama’s recently-introduced biosimilar substitution bill, HB 82.

View Mr. Spiegel’s presentation here. 

ASBM Shares Australian Physician Data with Australian Policymakers, Patient and Physician Groups

From February 14th to 16th, ASBM held a series of meetings with Australian regulators and policy makers, as well as pharmacy, physician and patient organizations. ASBM Executive Director Michael Reilly was joined by International Advisory Board member Stephen Murby, who is also the former head of the Consumers Health Forum.

Mr. Reilly and Mr. Murby met with the Australian Department of Health, the TGA, senior health officials in Parliament, Arthritis Australia, the Australian Diabetes Society, the Consumer Health Forum, Crohn’s and Colitis Australia, the Australian Rheumatology Association, the Gastroenterology Society of Australia, the Pharmacy Guild of Australia, and Medicines Australia.

The primary purpose of these meetings was to share the results of ASBM’s survey of 160 Australian prescribers of biologics on issues including how biosimilars are named, prescribed and monitored, in the hope that these data may be helpful to policymakers as biosimilars become more widely used in Australia. The Australian survey revealed that 76% of Australian prescribers support the Therapeutic Goods Administration (TGA) issuing distinct names for all biologics, including biosimilars.

In recent years, Australia has begun allowing the ‘a-flagging’ or pharmacy-level substitution of some biosimilars. The survey revealed that 90% of Australian prescribers consider it “very important” or “critical” that they and their patients determine which biologic medicine to use.

Similarly, 89% considered it “very important” or “critical” that they be notified in the event a patient receives a medicine at the pharmacy other than what they had been prescribed.

The full survey results may be read here.

ASBM’s Schneider Testifies in Support of AK Substitution Bill

On February 10th, ASBM Advisory Board Chair Philip Schneider, Associate Dean of University Arizona College of Pharmacy, testified by phone in support of SB 32, a biosimilar substitution bill being considered by the Alaska State Senate. Read ASBM’s letter of support for SB 32 here

Dr. Schneider emphasized the importance of keeping an accurate patient record, and the role of pharmacists in working collaboratively with physicians to bring the benefits of biosimilars safely to patients. He was joined by several Alaskan patients currently receiving biologic medicines who support SB 32 because of the new treatment options and reduced costs biosimilars will bring.

Reminder: Comments on FDA Draft Interchangeability Guidance Due March 20th

In its Draft Guidance on Interchangeability, the FDA has proposed that a biosimilar should undergo three successful switches (reference to biosimilar, biosimilar back to reference, reference back to biosimilar) providing at least 2 exposure periods to each product, to demonstrate interchangeability.

The deadline for comments is March 20th. 

The Guidance may be read here. 

Comments on the Draft Guidance may be submitted here.  

STATE SUBSTITUTION BILL ACTIVITY

Connecticut: A public hearing on HB 7118 was held on 3/2.

Iowa:  HSB38 and SSB1029 have passed the House and Senate and have been sent to Governor Terry Branstad for his signature. When signed, this will make Iowa the 28th State to enact biosimilar substitution legislation.

Montana HB 233 signed by the Governor Steve Bullock on 2/22, making Montana the 27th State to enact biosimilar legislation.

New Mexico HB 260 and SB 180 passed unanimously out of their respective committees. ASBM Advisory Board Chair Philip Schneider testified in support of both bills on 2/20.

Nevada Assembly Bill 245 (AB245) introduced 2/27, and referred to the Committee on Commerce and Labor

UPCOMING BIOSIMILAR EVENTS

Biosimilars & Follow-On Biologics 2017 Americas

Philadelphia, PA – March 20-22, 2017

29th Annual DIA EuroMeeting

Glasgow, Scotland – March 29-31, 2017

WHO 64th INN Consultation

Geneva, Switzerland – April 4, 2017

 

 


March 2017 Newsletter

March 5, 2017

 

newsletter | March 2017  
issue 56  

Who We Are

The Alliance for Safe Biologic Medicines is an organization composed of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, and others who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of ASBM to serve as an authoritative resource center for policy makers, the healthcare community and the general public on the issues surrounding biologic medications around the globe. 

Our Perspective

Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Therefore, ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety. We advocate, internationally as well as in the U.S., for policies that keep medical decisions between patients and physicians; seek solutions that ensure affordability and accessibility of biologic medicines; and avoid confusion while never compromising on patient safety.

For media inquiries please contact: michael@safebiologics.org
Alliance for Safe Biologic Medicines
PO Box 3691
Arlington, VA 22203
(703) 971 – 1700
Follow Us

Twitter: @SafeBiologics

Facebook

LinkedIn 

YouTube 

ASBM Submits Expression of Interest to participate in WHO Naming Meeting

On February 24th, ASBM submitted an Expression of Interest (EOI) to participate in the Open Session for Stakeholders at the 64th Consultation on International Nonproprietary Names, to be held April 4th, 2017. 

ASBM has been a regular participant at the INN Consultations since 2012, sharing the perspectives of healthcare providers regarding biologic naming with the INN Expert Group as it works to implement its naming proposal, known as the Biological Qualifier (BQ).

ASBM Advisory Board Chair Testifies in Support of NM Substitution Bills

On February 20th, ASBM Advisory Board Chair Philip Schneider, Associate Dean of University Arizona College of Pharmacy, testified before the New Mexico Legislature in support of its biosimilar substitution bill. Dr. Schneider appeared before the House Business and Industry Committee to support HB 260, and the Senate Corporations and Transportation Committee to support SB 180; both bills contain identical language.

From Dr. Schneider’s testimony:

“Current New Mexico law has no clear pathway for substitution of biosimilar drug products. [HB 260 and SB 180] will establish a clear substitution process by allowing pharmacists to dispense an FDA approved interchangeable biologic without first seeking approval…It will increase access to new treatment options and lower cost medicines for patients, without posing an undue burden on pharmacists. 27 states have passed similar legislation in the past few years.”

Both bills subsequently passed unanimously out of their respective committees.

ASBM Steering Committee Member Briefs Alabama Legislators

On February 16th, ASBM Steering Committee Member Andrew Spiegel, executive director of the Global Colon Cancer Association, represented ASBM at a briefing for Alabama lawmakers.

The lunch briefing, entitled “the Power of Biologics and Biosimilars: Revolutionizing Treatment for Patients with Serious Illnesses” featured Mr. Spiegel, who spoke of the great enthusiasm regarding biosimilars among the patient community. “Biosimilars will bring patients new treatment options at reduced cost”, Mr. Spiegel explained, “but physicians and pharmacists must work collaboratively and communicate with one another to ensure their safe use.”

Mr. Spiegel was joined at the briefing by an industry representative who outlined the science of biologics and biosimilars, and the sponsor of Alabama’s recently-introduced biosimilar substitution bill, HB 82.

View Mr. Spiegel’s presentation here. 

ASBM Shares Australian Physician Data with Australian Policymakers, Patient and Physician Groups

From February 14th to 16th, ASBM held a series of meetings with Australian regulators and policy makers, as well as pharmacy, physician and patient organizations. ASBM Executive Director Michael Reilly was joined by International Advisory Board member Stephen Murby, who is also the former head of the Consumers Health Forum.

Mr. Reilly and Mr. Murby met with the Australian Department of Health, the TGA, senior health officials in Parliament, Arthritis Australia, the Australian Diabetes Society, the Consumer Health Forum, Crohn’s and Colitis Australia, the Australian Rheumatology Association, the Gastroenterology Society of Australia, the Pharmacy Guild of Australia, and Medicines Australia.

The primary purpose of these meetings was to share the results of ASBM’s survey of 160 Australian prescribers of biologics on issues including how biosimilars are named, prescribed and monitored, in the hope that these data may be helpful to policymakers as biosimilars become more widely used in Australia. The Australian survey revealed that 76% of Australian prescribers support the Therapeutic Goods Administration (TGA) issuing distinct names for all biologics, including biosimilars.

In recent years, Australia has begun allowing the ‘a-flagging’ or pharmacy-level substitution of some biosimilars. The survey revealed that 90% of Australian prescribers consider it “very important” or “critical” that they and their patients determine which biologic medicine to use.

Similarly, 89% considered it “very important” or “critical” that they be notified in the event a patient receives a medicine at the pharmacy other than what they had been prescribed.

The full survey results may be read here.

ASBM’s Schneider Testifies in Support of AK Substitution Bill

On February 10th, ASBM Advisory Board Chair Philip Schneider, Associate Dean of University Arizona College of Pharmacy, testified by phone in support of SB 32, a biosimilar substitution bill being considered by the Alaska State Senate. Read ASBM’s letter of support for SB 32 here

Dr. Schneider emphasized the importance of keeping an accurate patient record, and the role of pharmacists in working collaboratively with physicians to bring the benefits of biosimilars safely to patients. He was joined by several Alaskan patients currently receiving biologic medicines who support SB 32 because of the new treatment options and reduced costs biosimilars will bring.

Reminder: Comments on FDA Draft Interchangeability Guidance Due March 20th

In its Draft Guidance on Interchangeability, the FDA has proposed that a biosimilar should undergo three successful switches (reference to biosimilar, biosimilar back to reference, reference back to biosimilar) providing at least 2 exposure periods to each product, to demonstrate interchangeability.

The deadline for comments is March 20th. 

The Guidance may be read here. 

Comments on the Draft Guidance may be submitted here.  

STATE SUBSTITUTION BILL ACTIVITY

Connecticut: A public hearing on HB 7118 was held on 3/2.

Iowa:  HSB38 and SSB1029 have passed the House and Senate and have been sent to Governor Terry Branstad for his signature. When signed, this will make Iowa the 28th State to enact biosimilar substitution legislation.

Montana HB 233 signed by the Governor Steve Bullock on 2/22, making Montana the 27th State to enact biosimilar legislation.

New Mexico HB 260 and SB 180 passed unanimously out of their respective committees. ASBM Advisory Board Chair Philip Schneider testified in support of both bills on 2/20.

Nevada Assembly Bill 245 (AB245) introduced 2/27, and referred to the Committee on Commerce and Labor

UPCOMING BIOSIMILAR EVENTS

Biosimilars & Follow-On Biologics 2017 Americas

Philadelphia, PA – March 20-22, 2017

29th Annual DIA EuroMeeting

Glasgow, Scotland – March 29-31, 2017

WHO 64th INN Consultation

Geneva, Switzerland – April 4, 2017

 

 


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