Posts – Page 41 – Safe Biologics

One of These is Not Like the Other …

November 7, 2016

Harry L. Gewanter, MD, FAAP, FACR

Chairman, ASBM

Since becoming involved with ASBM on the Medical Advisory Board and, more recently, as Chairman, I’ve learned a great deal about biosimilars. Being a pediatrician, I have found that analogies are an extraordinarily helpful means to explain complex issues. This video has proven to be an invaluable teaching tool when discussing the benefits and challenges of these medications:

They are not the same. They may be close, but they are not the same. Cookie Monster has hit the nail on the head.

Biosimilars may be highly similar to their reference products, but they are not the same. This is in contrast to generic versions of chemical medications which are identical. Being a reverse-engineered molecule designed to mimic the therapeutic properties of the originator, they may be close, but they are still not the same. While we hope and expect that these new molecules will behave in the same way as the originator molecule, there may be unexpected differences, such as unwanted immune responses.

The reality that biosimilars are close, but not the same as the originator molecules is at the core of the challenges faced by regulators, physicians, pharmacists and patients. Here are but a few of the various issues that must be reconciled if we are to reap the full potential benefits of these medications:

Approval: Biosimilars need to demonstrate that they are not only similar analytically, but that they also function similarly to their reference product. How much clinical data is needed and in how many conditions are sufficient to demonstrate this high similarity remains a subject of debate.

Naming: All biologic medications (both originators and biosimilars) must be clearly distinguished from one another in order to accurately track any benefits or problems to the correct product. The global use of these miracle biologic medications calls for a worldwide agreement on their names. Both the FDA and WHO have made distinct naming a priority, but have yet to announce an “official” system.

Labeling: Transparent, informative labeling assists physicians and patients to make more informed treatment decisions when choosing between similar products. Knowing if a product is the originator or a biosimilar or for what conditions each product has clinical data versus an extrapolated approval are two examples of important information that should be on a label. Labeling regulations vary from country to country, with Canada’s policies currently requiring the greatest degree of transparency.
Substitution: Physicians and patients need to know which product – the originator or the biosimilar – was dispensed by the pharmacy in order to accurately assess the medication’s effects. While no products are currently interchangeable in the United States, the potential for non-medical substitution exists.

Notification: A majority, but not all U.S. states have enacted laws requiring communication between pharmacists and prescribers if a biosimilar is dispensed when not specifically prescribed. How this communication is to be performed and within what time frame varies from state to state.

Put simply, as any preschooler – or muppet – knows, differences matter.

Physicians, pharmacists and patients are appropriately leery of using medications for which they may not have sufficient data or knowledge of the potential variations. To fully realize the potential benefits of biosimilars – such as improved access, additional treatment choices and lower costs – policies at all levels needs to reflect that reality.

ASBM Participates in AusBiotech 2016 Conference

October 26, 2016

During the last week of October, ASBM participated in the AusBiotech 2016 conference, which ran from the 24th-26th in Melbourne, Australia. The event attracted more than 2000 attendees, including Australian regulators, physicians, patients, researchers and biologic manufacturers.

Andrew Spiegel, executive director of the Global Colon Cancer Association, an ASBM Steering Committee member, represented ASBM at the conference.

Mr. Spiegel staffed ASBM’s booth, met with many attendees, including officials from the Australian Therapeutic Goods Administration (TGA); and, shared ASBM’s positions on issues relevant to Australia such as distinct naming and pharmacy-level substitution.

More information on Australian biosimilars policy may be found here.

ASBM Member Testifies in Support of BsUFA Reauthorization

October 20, 2016

On October 20th, representatives from the patient, physician, and pharmacist communities joined manufacturers of innovator biologics and biosimilars to discuss reauthorization of the Biosimilars User Fee Act (BsUFA). BsUFA is a five-year agreement between FDA and stakeholders that finances the FDA’s review of biosimilars through fees paid by biosimilar sponsors. It is set to expire in September 2017. The public meeting was held to discuss BsUFA’s proposed replacement, BsUFA II, at the FDA’s campus in Silver Spring, MD.

ASBM Steering Committee member group, the Global Colon Cancer Association, represented ASBM at the meeting. GCCA head Andrew Spiegel praised BsUFA’s track record in his remarks:

As patient advocates, we are extremely encouraged by the success of BsUFA in promoting both the safe and timely introduction of biosimilars. We’ve finally seen several biosimilars approved over the past year; and numerous other products are in various stages of the pipeline.

We can see the FDA’s cautious, science-based approach to biosimilar approval is working: take for example its use of distinguishable naming–both in the Zarxio approval and in subsequent approvals. It is critical for patients and providers to always be able to clearly identify which biologic product is being used throughout treatment. Accurate attribution of adverse events to the correct biologic is also necessary for long-term tracking of safety and efficacy.

Learn more about BsUFA II here.

Read Mr. Spiegel’s remarks here.

Click here to watch the full FDA Meeting.

ASBM Presents to WHO at 63rd INN Meeting

October 19, 2016

who63 — *ASBM President Doug Badger, left, and Advisory Board Chair Philip Schneider, at the WHO Headquarters in Geneva, Switzerland, October 18th, 2016*

On October 18th, in Geneva, Switzerland, ASBM President Doug Badger and Advisory Board Chair Philip Schneider, MS, FASHP participated in the World Health Organization’s 63rd Stakeholder Consultation on International Nonproprietary Names.

The subject of the INN meeting is the continued development 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. This is the eighth INN Consultation at which ASBM has shared its perspectives with the INN Expert Group.
As a condition of participation, ASBM was asked by the WHO to refrain from discussing details about the meeting until the Executive Summary is made available to the public in the coming months.

The Executive Summary from the 62nd INN Consultation, held on April 12th, may be viewed here, and ASBM’s presentation from that meeting may be viewed here.

ASBM Holds Webinar for Ontario Hospital Assocation

October 12, 2016

On October 12th, in Toronto, Ontario, ASBM participated in an educational webinar for the Ontario Hospital Association, which represents 150 hospitals in the Canadian province. ASBM Executive Director Michael Reilly participated on a panel with Canadian physicians, patients, and industry representatives. Around 100 attendees were present.

Mr. Reilly discussed the state of biosimilar uptake globally. He described U.S. and European polices on biosimilar approval, naming and substitution, and how they compare and contrast to those of Canada.

ASBM Meets with Health Policymakers in Alberta, Participates in Biosimilars Forum

October 6, 2016

On October 5th, ASBM Executive Director Michael Reilly and Steering Committee member Andrew Spiegel of the Global Colon Cancer Association, met with Health Alberta regulators to offer ASBM’s perspectives on Canadian biosimilar policy. Reilly and Spiegel shared data from ASBM’s survey of Canadian prescribers. ASBM counts 12 Canadian patient groups among its membership, and ASBM member IAPO represents 10 Canadian member groups.

The primary purpose of the meeting was to discuss Alberta’s consideration of the automatic switching of naive patients to the biosimilar Inflectra for cost, rather than medical reasons. Unlike chemical generics, biosimilars are not identical to their reference products; thus, Non-Medical Switching is of great concern to patients treated with biologics.

ASBM also met with Drew Barnes, a Member of the Legislative Assembly, to discuss these concerns. MLA Barnes is Chief Opposition Health Critic in the Alberta Legislature.

The following day, October 6th, Mr. Reilly and Mr. Speigel participated in a biosimilars forum held by Canada’s Institute for Health Economics, where Mr. Reilly spoke at a breakout session. While critical of provincial NMS policies, Mr. Reilly praised Canada’s overall record on biosimilars. “Health Canada has been very patient-centric when approving biosimilars, particularly in its caution regarding indication extrapolation, but also in its support for the WHO’s distinct naming plan and its biosimilar labeling guidance, which leads the world in its transparency requirements, ” said Reilly.

Read more about the IHE forum here.

Op-Ed: Protect Patients with Open Communication

October 6, 2016

On September 30th, An op-ed appeared in the Detroit News, authored by Marcia Horn, President and CEO of the International Cancer Advocacy Network (ICAN), an ASBM Steering Committee member. Ms. Horn discusses how legislation permitting biosimilar substitution could help Michigan patients. Similar legislation has been passed in 25 states and Puerto Rico. A key provision of the legislation is a requirement for pharmacists to communicate in a timely manner which biologic- the originator product or the biosimilar- was dispensed to the patient. This allows an accurate patient record to be kept, and for the patient’s response to treatment to be accurately assessed by the physician.

ASBM Chairman Harry Gewanter MD, and Andrew Spiegel, executive director of the Global Colon Cancer Association; both testified Jan 19th, 2016 in support of HB 4812 in a Michigan Senate Health Committee hearing. The bill had passed the Michigan House of Representatives 101-5 in November 2015, but the provision requiring communication between pharmacist and physician was ultimately stripped from the Senate version.

Read ASBM’s letter of support for HB 4812 here.

FDA Approves Fourth Biosimilar

September 29, 2016

On Friday, September 23rd the FDA approved its fourth biosimilar, Amjevita (adalimumab-atto).

Amjevita (adalimumab-atto) was approved for seven adult indications of its reference product, Humira (adalibumab):

moderately to severely active rheumatoid arthritis;
active psoriatic arthritis;
active ankylosing spondylitis (an arthritis that affects the spine);
moderately to severely active Crohn’s disease;
moderately to severely active ulcerative colitis; and
moderate to severe plaque psoriasis.

Like the three previously-approved biosimilars, Amjevita (adalimumab-atto) is not approved as interchangeable. Only an interchangeable biosimilar may be substituted for the reference product by a pharmacist without the intervention of the health care provider who prescribed the reference product.

Read the FDA’s Press Release about that approval here.

ASBM Latin American Chapter Joins Biosimilars Forum in Brazil

September 28, 2016

SÁO PAULO, BRAZIL- The Latin American Chapter of the Alliance for Safe Biologic Medicines (ASBM) and the Global Colon Cancer Association (GCCA) today participated in a biologics and biosimilars forum in Sáo Paulo, Brazil. The chapter is comprised of eight patient organizations representing a variety of disease groups including multiple forms of cancer, hepatitis, and neurological conditions. The forum, entitled “What Patients Need to Know About Biologic Medicines and Biosimilars” was held as part of the 3^rd Brazilian Congress All Together Against Cancer and was attended by more than 300 patient advocates, mostly from Latin America.

spiegel-saopaulo2

asbmgcca_edu3169 — *Mr. Spiegel offers patient perspectives on biosimilars.*

Andrew Spiegel, executive director of GCCA and a founding member of ASBM, moderated the two-hour discussion about biosimilars- attempts to create lower-cost copies of biologic medicines which treat serious conditions like rheumatoid arthritis, psoriasis, and a variety of cancers. Unlike generic versions of chemical drugs, biosimilars are not exact copies of the originator products- they are merely “similar”. These differences can create unexpected effects in patients, including unwanted immune responses. Polices regarding their use must reflect these concerns, Mr. Spiegel argued: “Biosimilars hold great promise for patients in Latin America, offering them new choices at lower cost- but in order to realize these benefits, patient and physicians need to be confident in their safety and effectiveness”.

Valderílio Azevedo MD, rheumatologist from the Federal University of Paraná, and ASBM Chairman Harry L Gewanter MD provided the physician perspective on biosimilars.

asbm-latam_edu3398 — *ASBM Chairman Harry L Gewanter MD shares data from a survey of 399 biologic prescribers in four Latin American countries.*

Dr. Gewanter shared results of a survey of 399 prescribers of biologic medicines from four Latin America countries: Argentina, Brazil, Colombia and Mexico. ASBM recently presented these data to the XIX Pan American League of Associations for Rheumatology Congress in Panama City, Panama in April; and at the 6^th Latin American Forum on Biosimilars in Brasília, Brazil in June.

The survey revealed a need for clear naming for all biologics, including biosimilars: 57% of respondents referred to a biologic medicine exclusively by its non-proprietary name in a patient record (which could result in patients receiving the wrong medicine). Further, some 28% used the non-proprietary name exclusively when reporting adverse events (which could result in attribution to the wrong medicine).

_edu3522 — From left to right: Zorana Moravic of EuropaColon, Barry Stein of the Colorectal Cancer Association of Canada, Luciana Holtz of Brazil’s Oncoguia Institute, Andrew Spiegel of the Global Colon Cancer Association, and ASBM Chairman Harry Gewanter MD.

The World Health Organization (WHO), which issues international non-proprietary names, has proposed to differentiate similar medicines from one another by the use of a biological qualifier (BQ), a unique four-letter code added to a shared root name. The survey revealed that 94% of respondents considered the BQ “useful in helping ensure their patients receive the right medicine”.

Carolina Cohen, Director of ABRALE, the Brazilian Association for Lymphoma and Leukemia, an ASBM member which idealized and organized the larger conference, emphasized the need for patients and physicians to educate themselves about biosimilars, and to engage their regulatory authorities. “Currently the level of patient protections in biosimilar policy varies widely from country to country. ABRALE believes that patients should be able to expect safe and effective biosimilars in whichever country they receive treatment. ASBM has worked globally since 2010 to educate on these medicines and promote their safe use.”

The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals including patients, physicians, pharmacists, manufacturers of both innovative and biosimilar medicines and others, working together to ensure patient safety remains 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
Email: Michael@safebiologics.org

# # #

ASBM Latin American Chapter Joins Biosimilars Forum in Brazil

September 28, 2016

SÁO PAULO, BRAZIL- The Latin American Chapter of the Alliance for Safe Biologic Medicines (ASBM) and the Global Colon Cancer Association (GCCA) today participated in a biologics and biosimilars forum in Sáo Paulo, Brazil. The chapter is comprised of eight patient organizations representing a variety of disease groups including multiple forms of cancer, hepatitis, and neurological conditions. The forum, entitled “What Patients Need to Know About Biologic Medicines and Biosimilars” was held as part of the 3^rd Brazilian Congress All Together Against Cancer and was attended by more than 300 patient advocates, mostly from Latin America.

spiegel-saopaulo2

Andrew Spiegel, executive director of GCCA and a founding member of ASBM, moderated the two-hour discussion about biosimilars- attempts to create lower-cost copies of biologic medicines which treat serious conditions like rheumatoid arthritis, psoriasis, and a variety of cancers. Unlike generic versions of chemical drugs, biosimilars are not exact copies of the originator products- they are merely “similar”. These differences can create unexpected effects in patients, including unwanted immune responses. Polices regarding their use must reflect these concerns, Mr. Spiegel argued: “Biosimilars hold great promise for patients in Latin America, offering them new choices at lower cost- but in order to realize these benefits, patient and physicians need to be confident in their safety and effectiveness”.

Valderílio Azevedo MD, rheumatologist from the Federal University of Paraná, and ASBM Chairman Harry L Gewanter MD provided the physician perspective on biosimilars.

Dr. Gewanter shared results of a survey of 399 prescribers of biologic medicines from four Latin America countries: Argentina, Brazil, Colombia and Mexico. ASBM recently presented these data to the XIX Pan American League of Associations for Rheumatology Congress in Panama City, Panama in April; and at the 6^th Latin American Forum on Biosimilars in Brasília, Brazil in June.

The survey revealed a need for clear naming for all biologics, including biosimilars: 57% of respondents referred to a biologic medicine exclusively by its non-proprietary name in a patient record (which could result in patients receiving the wrong medicine). Further, some 28% used the non-proprietary name exclusively when reporting adverse events (which could result in attribution to the wrong medicine).

The World Health Organization (WHO), which issues international non-proprietary names, has proposed to differentiate similar medicines from one another by the use of a biological qualifier (BQ), a unique four-letter code added to a shared root name. The survey revealed that 94% of respondents considered the BQ “useful in helping ensure their patients receive the right medicine”.

Carolina Cohen, Director of ABRALE, the Brazilian Association for Lymphoma and Leukemia, an ASBM member which idealized and organized the larger conference, emphasized the need for patients and physicians to educate themselves about biosimilars, and to engage their regulatory authorities. “Currently the level of patient protections in biosimilar policy varies widely from country to country. ABRALE believes that patients should be able to expect safe and effective biosimilars in whichever country they receive treatment. ASBM has worked globally since 2010 to educate on these medicines and promote their safe use.”

The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals including patients, physicians, pharmacists, manufacturers of both innovative and biosimilar medicines and others, working together to ensure patient safety remains 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
Email: Michael@safebiologics.org

# # #