Safe Biologics

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On July 25th, the U.S. Senate Committee on Finance passed the Prescription Drug Pricing Reduction Act (PDPRA) of 2019, in a vote of 19-9. On July 29th, ASBM released a statement outlining concerns with one of the bill’s provisions. From the statement:

The stated aims of the bill include lowering prescription drug prices and boosting biosimilar uptake; these goals are shared by ASBM and many others in the physician and patient advocacy community. One provision in the PDPRA, however, raises serious concerns.

According to the bill, higher reimbursement rates will be paid to physicians who prescribe biosimilar biologic products under Medicare Part B than originator biologic products. If implemented, this plan to provide the doctor a 33% bonus for use of a biosimilar would insert financial incentives where patient interests should prevail. Every patient should be confident that their physician will prescribe the product that is in their best interest…not the one that is the most profitable to the physician personally. This proposed scheme fundamentally undermines the patient-physician relationship of trust.

ASBM’s position has been and continues to be that treatment decisions should be based on what is best for the patient, unfettered by third-party influence. That decision should take into consideration a number of factors, including the affordability of the drug for the patient, not profit for the physician.

Read the full statement here. 

ASBM Poster Abstract Accepted at ESMO Congress 2019

ASBM Joins Patient Advocacy Groups in Opposing Shared CMS Billing Codes for Multiple Biologic Products

ASBM was represented at DIA 2019 by Executive Director Michael Reilly and Advisory Board Chair Philip Schneider, both of whom met with conference attendees to discuss ASBM’s work. Among the booth’s visitors was WHO INN Programme Lead Dr. Raffaella Balocco, who was a speaker at a panel on global pharmacovigilance.

Literature was distributed at ASBM’s booth on key biosimilar policy issues including: biosimilar basics, distinct naming, substitution and interchangeability, product labeling, indication extrapolation, and international harmonization of biologic nomenclature.

On Thursday, June 27th, Dr. Schneider participated in a session entitled “Successes and Challenges in Pharmacovigilance for Biologics and Biosimilars“. In his presentation, Schneider discussed the importance of redundancy in high reliability systems, with respect to clear product identification and biologic naming. Schneider noted that in Europe, where multiple biosimilars share a nonproprietary name with the originator biologic upon which they are based, roughly a third of adverse event reports for infliximab products do not identify the specific product responsible by its brand name.

View Dr. Schneider’s presentation here. 

Read more about the ASBM’s DIA exhibit and presentation here. 

On June 24th, the Vancouver Sun published an op-ed by ASBM Executive Director Michael Reilly expressing concern about a recently-announced British Columbia mandated-switching policy. The policy, announced May 27th, will forcibly switch 23,000 patients to biosimilars in the coming months.

The op-ed points out that the proposed forced switch policy in BC misconstrues the European experience with biosimilars which has primarily left medical decisions in the hands of the treating physicians. From the op-ed:

Biosimilars have increased competition, expanded the choice of products physicians can choose from, increased the number of patients with access to these highly effective biologics, and provided headroom to fund innovative drugs.

However, it is important to note that in the vast majority of European countries, the decision of what medicine to choose has remained with the treating physician in consultation with their patient — contrary to the government mandated forced switch of well-treated patients announced by [BC Health Minister Adrian] Dix.

Furthermore, Health Canada, like the European Medicines Agency, recommends that a decision to switch a patient being treated with a reference biologic drug (innovator product) to a biosimilar should be made by the treating physician in consultation with the patient and taking into account available clinical evidence and any policies of the relevant jurisdiction.

Read the full op-ed here. 

Read ASBM’s Fact Sheet covering the differences between BC and EU substitution policies here.

From June 4th-6th, ASBM exhibited at the 2019 BIO International Convention held in Philadelphia, PA. Each year, the Convention attracts approximately 16,000 attendees from more than 5,000 companies and from 70 different countries.

ASBM was represented at the booth by Andrew Spiegel, ASBM Steering Committee member and executive director of the Global Colon Cancer Association. Conference attendees met with Mr. Spiegel and discussed key biosimilar policy issues including biosimilar naming and non-medial switching policy.

While at the BIO Convention, Mr. Spiegel also participated in a panel discussion with other patient advocates and biologic manufacturers to discuss the importance to patients of building a sustainable biosimilar market.

Read more about the 2019 Bio Convention here. 

During the month of June, the FDA approved two new biosimilars, bringing the total approved to 21.

The first product, ZIRABEV® (bevacizumab-bvzr) is biosimilar to AVASTIN® (bevacizumab). Like its reference product, it is a vascular endothelial growth factor inhibitor indicated for the treatment of metastatic colorectal cancer. It is the second bevacizumab biosimilar approved by the FDA.

The second product, KANJINTI® (trastuzumab-anns) is biosimilar to HERCEPTIN® (trastuzumab). Like its reference product, it is a HER2/neu receptor antagonist indicated for the treatment of HER2 overexpressing breast cancer and the treatment of HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. It is the fifth trastuzumab biosimilar approved by the FDA.

ESMO Congress 2019

Barcelona, Spain – September 27-October 1

World Biosimilar Congress 2019 – Europe 

Basel, Switzerland – October 15-16

WHO 69th INN Consultation

Geneva, Switzerland – October 22

DIA Annual Canadian Meeting

Gatineau, Quebec – November 5-6
 

Twitter: @SafeBiologics

Facebook

LinkedIn 

YouTube 

On July 25th, the U.S. Senate Committee on Finance passed the Prescription Drug Pricing Reduction Act (PDPRA) of 2019, in a vote of 19-9. On July 29th, ASBM released a statement outlining concerns with one of the bill’s provisions. From the statement:

The stated aims of the bill include lowering prescription drug prices and boosting biosimilar uptake; these goals are shared by ASBM and many others in the physician and patient advocacy community. One provision in the PDPRA, however, raises serious concerns.

According to the bill, higher reimbursement rates will be paid to physicians who prescribe biosimilar biologic products under Medicare Part B than originator biologic products. If implemented, this plan to provide the doctor a 33% bonus for use of a biosimilar would insert financial incentives where patient interests should prevail. Every patient should be confident that their physician will prescribe the product that is in their best interest…not the one that is the most profitable to the physician personally. This proposed scheme fundamentally undermines the patient-physician relationship of trust.

ASBM’s position has been and continues to be that treatment decisions should be based on what is best for the patient, unfettered by third-party influence. That decision should take into consideration a number of factors, including the affordability of the drug for the patient, not profit for the physician.

Read the full statement here. 

ASBM Poster Abstract Accepted at ESMO Congress 2019

ASBM Joins Patient Advocacy Groups in Opposing Shared CMS Billing Codes for Multiple Biologic Products

ASBM was represented at DIA 2019 by Executive Director Michael Reilly and Advisory Board Chair Philip Schneider, both of whom met with conference attendees to discuss ASBM’s work. Among the booth’s visitors was WHO INN Programme Lead Dr. Raffaella Balocco, who was a speaker at a panel on global pharmacovigilance.

Literature was distributed at ASBM’s booth on key biosimilar policy issues including: biosimilar basics, distinct naming, substitution and interchangeability, product labeling, indication extrapolation, and international harmonization of biologic nomenclature.

On Thursday, June 27th, Dr. Schneider participated in a session entitled “Successes and Challenges in Pharmacovigilance for Biologics and Biosimilars“. In his presentation, Schneider discussed the importance of redundancy in high reliability systems, with respect to clear product identification and biologic naming. Schneider noted that in Europe, where multiple biosimilars share a nonproprietary name with the originator biologic upon which they are based, roughly a third of adverse event reports for infliximab products do not identify the specific product responsible by its brand name.

View Dr. Schneider’s presentation here. 

Read more about the ASBM’s DIA exhibit and presentation here. 

On June 24th, the Vancouver Sun published an op-ed by ASBM Executive Director Michael Reilly expressing concern about a recently-announced British Columbia mandated-switching policy. The policy, announced May 27th, will forcibly switch 23,000 patients to biosimilars in the coming months.

The op-ed points out that the proposed forced switch policy in BC misconstrues the European experience with biosimilars which has primarily left medical decisions in the hands of the treating physicians. From the op-ed:

Biosimilars have increased competition, expanded the choice of products physicians can choose from, increased the number of patients with access to these highly effective biologics, and provided headroom to fund innovative drugs.

However, it is important to note that in the vast majority of European countries, the decision of what medicine to choose has remained with the treating physician in consultation with their patient — contrary to the government mandated forced switch of well-treated patients announced by [BC Health Minister Adrian] Dix.

Furthermore, Health Canada, like the European Medicines Agency, recommends that a decision to switch a patient being treated with a reference biologic drug (innovator product) to a biosimilar should be made by the treating physician in consultation with the patient and taking into account available clinical evidence and any policies of the relevant jurisdiction.

Read the full op-ed here. 

Read ASBM’s Fact Sheet covering the differences between BC and EU substitution policies here.

From June 4th-6th, ASBM exhibited at the 2019 BIO International Convention held in Philadelphia, PA. Each year, the Convention attracts approximately 16,000 attendees from more than 5,000 companies and from 70 different countries.

ASBM was represented at the booth by Andrew Spiegel, ASBM Steering Committee member and executive director of the Global Colon Cancer Association. Conference attendees met with Mr. Spiegel and discussed key biosimilar policy issues including biosimilar naming and non-medial switching policy.

While at the BIO Convention, Mr. Spiegel also participated in a panel discussion with other patient advocates and biologic manufacturers to discuss the importance to patients of building a sustainable biosimilar market.

Read more about the 2019 Bio Convention here. 

During the month of June, the FDA approved two new biosimilars, bringing the total approved to 21.

The first product, ZIRABEV® (bevacizumab-bvzr) is biosimilar to AVASTIN® (bevacizumab). Like its reference product, it is a vascular endothelial growth factor inhibitor indicated for the treatment of metastatic colorectal cancer. It is the second bevacizumab biosimilar approved by the FDA.

The second product, KANJINTI® (trastuzumab-anns) is biosimilar to HERCEPTIN® (trastuzumab). Like its reference product, it is a HER2/neu receptor antagonist indicated for the treatment of HER2 overexpressing breast cancer and the treatment of HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. It is the fifth trastuzumab biosimilar approved by the FDA.

ESMO Congress 2019

Barcelona, Spain – September 27-October 1

World Biosimilar Congress 2019 – Europe 

Basel, Switzerland – October 15-16

WHO 69th INN Consultation

Geneva, Switzerland – October 22

DIA Annual Canadian Meeting

Gatineau, Quebec – November 5-6
 

Twitter: @SafeBiologics

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On May 24th, ASBM presented at the World Biosimilars Congress USA 2018 in San Diego, CA. The theme of the two-day conference was “Helping the global industry bring biosimilars to the US” and it drew more than 100 attendees including representatives from the industry, health care professionals, and payers.

ASBM Advisory Chair Philip Schneider gave a presentation entitled “Biologic nomenclature: Implementation of an internationally harmonized system”. The presentation offered an overview of the state of international harmonization in the area of biologic naming, including examination of the naming policies of major national regulators and views of health professionals worldwide regarding the need for all biologics, including biosimilars to have distinct non-proprietary names.

Dr. Schneider discussed the feasibility of four-letter suffixes -as proposed by the World Health Organization (WHO) and enacted by the U.S. Food and Drug Administration (FDA)- in addressing this need. He also offered his observations from ASBM’s April 11th naming forum in Washington, DC and his April 30th meeting with WHO in Geneva, emphasizing the importance of the WHO assuming a leadership role on this issue:

“International harmonization is key to building a strong global system of pharmacovigilance, and countries without robust pharmacovigilance systems in place may benefit the most from distinct naming and international harmonization. WHO leadership is essential to achieve this and avoid further proliferation of country-specific naming schemes.”

View Dr. Schneider’s presentation here. 

On May 23rd-24th, ASBM attended the International Alliance of Patients’ Organizations 8^th Global Patients Congress.

The meeting was attended by approximately 80 different patient groups and 130 participants from around the globe which convene on a number of health topics—including sessions on how best to engage regulators worldwide and a 101 on biosimilar medicines. ASBM also hosted a booth which highlighted the importance of the harmonization of naming schemes for biologics and biosimilars and included a poster presentation of results from physicians in 12 countries surveyed by ASBM.  View the poster here.

At the meeting ASBM Steering Committee member and Global Colon Cancer Association Executive Director, Andrew Spiegel, was named as the Chair-elect to be IAPO Chairman in August of 2020.

“We send ASBM’s congratulations to Andy for his recognition as a top notch global patient advocate and look forward to his leadership at IAPO,” stated Dr. Madelaine Feldman, ASBM Chair. 

ASBM Welcomes New Member Esperantra

At the 2018 IAPO meeting, ASBM engaged with many patient organizations and as a result would like to welcome Esperantra to ASBM membership.

Esperantra is a non-profit organization created for the purpose of contributing to the reduction of cancer mortality in Peru by improving the quality of life of cancer patients, and advocating for equality in access to quality treatments and to innovative care.  Esperantra is the first organization of its kind to provide information and support, and to advocate on behalf of cancer patients through its different programs.  Their mission is to inform, educate and empower people to achieve a timely diagnosis through prevention programs and to access treatments to control the disease.

Through the meeting of Director Karla Ruiz De Castilla Yabar, ASBM learned that Esperantra has been following regulations in their country on biologic medicines and been active in giving lectures on the issue.

We welcome Esperantra to ASBM’s membership—especially as we tackle such global issues as the naming of biologics and biosimilars,” stated ASBM Executive Director, Michael Reilly.  “All patients, no matter what continent they live, should be able to benefit from knowing that their medicines are safe and effective. The harmonization of biologic naming will benefit all patients, no matter where they are being treated.”

Learn more about Esperantra here. 

On May 17th, ASBM presented an abstract during the poster session at the World Health Professions Regulation Conference 2018 in Geneva, Switzerland.

ASBM’s poster, entitled “How do policymakers realize the cost-savings from biosimilars while maintaining healthcare provider autonomy?” draws from ASBM’s surveys of 1,832 physicians in 12 countries and 401 pharmacists in the U.S.

The findings were presented by ASBM’s International Advisory Board Chair, Philip J. Schneider, MS, FASHP, FASPEN, FFIP; who co-authored the abstract with ASBM Executive Director, Michael Reilly, Esq.

The conference, in its fifth year, is sponsored by the World Health Professions Alliance, an international organization representing dentists, nurses, pharmacists, physicians, and physical therapists.

Read more about WHPRC 2018 here. 

View the poster here. 

On May 15th, the U.S. Food and Drug Administration approved its tenth biosimilar, Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery.

“It is important for patients to have access to safe, effective and affordable biological products and we are committed to facilitating the development and approval of biosimilar and interchangeable products,” said Leah Christl, Ph.D., director of the Therapeutic Biologics and Biosimilars Staff in the FDA’s Center for Drug Evaluation and Research. “Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs.”

The FDA’s approval of Retacrit is based on a review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Retacrit is biosimilar to Epogen/Procrit. Retacrit has been approved as a biosimilar, not as an interchangeable product.

Read more about the FDA’s approval here. 

On May 10th, ASBM Chair Madelaine Feldman testified in support of Illinois House Bill 4146, which essentially forbids mid-year formulary change on a patient who is stable on their medicine. Other proponents included the Coalition of State Rheumatology Organizations, an ASBM member, and patient advocacy groups including the Arthritis Foundation.

The bill passed the Senate on May 25th and has been placed on the House Calendar of Order for Concurrence with Senate Amendments.
Read more about HB 4146 here. 

Connecticut: On May 22nd, the House transmitted S 197 to Governor Dannel Malloy for signature.

New Hampshire: On May 3rd, HB 1791 was passed by the Senate and sent to Governor Chris Sununu for signature.  On June 7th, there was a signing ceremony by Governor Sununu.   Read ASBM’s letter urging Governor Sununu to sign HB 1791 here. 

Vermont: On May 30th, Governor Phil Scott signed S 92, making Vermont the 42nd state to enact biosimilar substitution legislation.

DIA Annual Conference

Boston, MA – June 24-28

International Pharmaceutical Federation Meeting

Glasgow, Scotland – September 1

Rhode Island Health Systems Pharmacists CE Course

Providence, RI – September 26

Long Island University College of Pharmacy CE Course

Queens, NY – September 30

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Biologic medicines treat serious conditions including rheumatoid arthritis, psoriasis, and cancer. Lower-cost versions, called biosimilars, offer new therapeutic choices but unlike generics are not exact copies of the originator. These inherent differences spurred the FDA to implement a system of distinct suffixes to ensure clear product identification; the comment period on a recent update to the policy closed May 7th.

Support for the recent update to the FDA policy was very strong and diverse. A joint letter of support was submitted by physician organizations including 24 national and state rheumatology associations and Harvard Medical School.

ASBM was among the more than 100 patient advocacy organizations that submitted comments or signed on to letters of support for the policy, as did 124 individual patients, nurses, and other health care providers. A letter of support was also submitted from two past presidents of the American Pharmacists Association and the American Society of Health-system Pharmacists.
In addition to the submitted comments, results from a May 2019 survey of 202 biologic prescribers were shared with FDA; in which 85% said they “strongly agree” or “somewhat agree” with the FDA’s policy of adding 4-letter suffixes. Only 7% strongly or somewhat disagree with the policy, while 8% were “unsure”.
Physicians were strongly supportive of recent updates to the FDA policy, including the decision not to retrospectively rename previously approved products with suffixes: 71% agreed with the FDA’s decision not to rename previously-approved biologics with suffixes, and 67% agreed with the FDA’s decision not to rename insulin, desirudin, and somatropin products previously approved under the Food Drug and Cosmetics Act.
Respondents were drawn equally from specialties in which biologics are routinely prescribed, including rheumatology, gastroenterology, endocrinology, oncology, dermatology, neurology, immunology,
nephrology, and ophthalmology.

Read ASBM’s press release and about the comments and survey here. 

The full survey may be viewed here.

Read the full FDA Statement here and the Final Guidance here. 

In late April, FDA approved Eticovo (etanercept-ykro), the second biosimilar for etanercept.

Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Etanercept is indicated for the treatment of rheumatoid, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis.

Eticovo has been approved across all eligible indications, namely ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis and rheumatoid arthritis.

Read more about the FDA approval here.

On April 2nd, ASBM Chair Madelaine Feldman, MD, FACR; and Advisory Board Chair, Philip Schneider, MS, FASHP presented before the 68th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. This was the twelfth INN Consultation at which ASBM has presented since 2013.

While the discussions in the Open Session at which ASBM presented are bound by confidentiality agreements pending the publication of an Executive Summary by the INN Programme, the Executive Summary for the 67th INN Consultation may be viewed here.

ASBM surveys have consistently shown strong support for distinct naming among physicians worldwide. Sixty-six percent of U.S. physicians surveyed support distinct naming for all biologics including biosimilars, as do 68% of Canadian and 79% of Australian physicians. Among physicians in Latin America, 94% believe the WHO’s BQ proposal would be helpful in ensuring their patients receive the correct medicine.

In the past year, ASBM has held three meetings to discuss international harmonization of biologic nomenclature. Participants included representatives from the FDA, Health Canada, the WHO, physician and pharmacist societies, and patient advocacy organizations. The first two meetings took place in April and July 2018 in Washington, DC, and the third in March 2019 in Ottawa, Ontario. A white paper on the first of these meetings may be read here. 

Digestive Disease Week

San Diego, CA – May 18-21

BIO International Convention

Philadelphia, PA – June 3-5

DIA Annual Meeting

San Diego, CA – June 23-27
 

Twitter: @SafeBiologics

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From March 22nd-24th, ASBM exhibited at the Annual Meeting of the American Pharmacists Association (APhA), held in Seattle, Washington. Founded in 1852, APhA is the largest association of pharmacists in the United States, with more than 62,000 practicing pharmacists, pharmaceutical scientists, student pharmacists, and pharmacy technicians as members.
ASBM was represented at its booth by Advisory Board Chair Philip Schneider, past president of the American Society of Healthsystem Pharmacists (ASHP) and Advisory Board Member Ronald Jordan, Dean of the Chapman University College of Pharmacy and past president of APhA.
Dr. Schneider answered questions about biosimilar policy issues which affect pharmacy practice, including naming practices in the US and internationally. US biosimilar substitution policy, which varies by state, was also discussed.
Read more about ASBM’s APhA exhibit here. 

On March 21st, Mississippi Governor Phil Bryant signed Senate Bill 2365, making Mississippi the 46th U.S. State to enact legislation permitting pharmacists to substitute a biosimilar once approved by the FDA as interchangeable.

The law requires pharmacists to communicate to the prescriber within 5 business days which product- the reference or the biosimilar- was dispensed. This ensures that all parties maintain an accurate patient record, that physicians can accurately assess a patients’s response to a particular treatment, and can make informed decisions. Physicians also retain the authority to prevent a substitution they deem medically inappropriate.

On February 6th, ASBM Chair Madelaine Feldman participated in a briefing for Mississippi legislators to discuss the bill.

Read about the legislation here.

Trastuzumab-qyyp is used to treat patients with HER-2 overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
Read more about the approval here. 

ASBM released a statement is support of the updated guidance, which said in part:

ASBM commends the decision by FDA to apply distinguishable suffixes to all biologics, including interchangeable biosimilars going forward. FDA’s decision puts in place a protocol for a safe future, when there are many more biologics, biosimilars and interchangeable biosimilars.

The full statement may be read here.
The difficulties associated with applying distinguishing suffixes to previously-approved biologics were cited as a contributing factor to Health Canada’s recent decision not to harmonize nomenclature its with FDA’s system following extensive discussions.
However, the new guidance explains that the agency will continue to assign suffixes to newly approved innovator biologics, biosimilars, or interchangeable biosimilars. With regard to interchangeable biosimilars (those which can be substituted at the pharmacy level without physician involvement), the Agency made clear that an approved biosimilar’s suffix would not be changed should it subsequently be designated interchangeable.
Finally, FDA clarified its treatment of so-called “transition products”
including insulins, that were approved under the Section (505) of the Food, Drug and Cosmetic Act which will be deemed biosimilars as of March 23, 2020. These products also will not be renamed with new suffixes.
Read the full Guidance here.
Comments on the Guidance are due by May 7th and may be submitted here.

On March 6th, 2019, ASBM hosted the third in a series of meetings with regulators to discussion the international harmonization of biologic nomenclature. Participants included representatives from Health Canada, the FDA, and the World Health Organization. Other participants included members of canadian physician and patient advocacy organizations from the disease states commonly treated with biologic medicines.

The meeting, held in Ottawa, Ontario served as a follow-up to prior meetings held during April and July in Washington, DC.
The April 11th meeting was the subject of a recent whitepaper prepared by Scientific American, which co-hosted the meeting.

Read more about the whitepaper here. 

Read more about the meeting here. 

On March 1st, The first of a series of videos featuring ASBM Chair Madelaine Feldman, MD FACR was published by the Center for Biosimilars on their webiste, in which Dr. Feldman discusses prescriber persepctives on biosimilar education and interchangeability.

The video was recorded in January at the group’s New Jersey studios, at a forum comprised of pharmacists, clinicians, and representatives from biosimilar development companies.
Watch the video here. 

Digestive Disease Week

San Diego, CA – May 18-21

BIO International Convention

Philadelphia, PA – June 3-5

DIA Annual Meeting

San Diego, CA – June 23-27
 

Twitter: @SafeBiologics

Facebook

LinkedIn 

YouTube 

On March 6th, 2019, ASBM will host the third in a series of meetings with regulators to discussion the international harmonization of biologic nomenclature. Participants will include representatives from Health Canada and the FDA.

The meeting, to be held in Ottawa, Ontario will serve as a follow-up to prior meetings held during April and July in Washington, DC. In addition to the regulators, participants will include members of leading physician and pharmacist societies, and patient advocates from the disease states commonly treated with biologic medicines.
The April 11th meeting was the subject of a recent whitepaper prepared by Scientific American, which co-hosted the meeting.

Read more about the whitepaper here. 

In January a biosimilar switching study appeared in the journal Annals of Rheumatologic Diseases (ARD), published by the European League Against Rhematism (EULAR).

The study which examines the results of a mandated switch from orginator etanercept to a biosimilar among Danish patients with rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis. It is an observational switching study of more than 2000 patients that compared switchers, non-switchers, back-switchers with each other and a historical cohort.

Its findings demonstrate the safety of the biosimilar as well as variability in patient response, with patient characteristics and disease state influncing outcomes more than any noted drug effects. These observations highlight the importance of physician and patient control of treatment decisions.

Read the study here. 

On January 18, the FDA approved Onzutrant (trastuzumab-dttb) for three cancer indications. It is the third biosimilar to trastuzumab, and the 16th biosimilar approved by the FDA since approving its first less than 4 years ago.

Like its reference product, trastuzumab-dttb it is used to treat breast and gastric cancers. Ontruzant was approved in 2017 by the European Medicines Agency for use in the EU.

The approval comes just one month after the FDA’s approval of its second trastuzumab biosimilar, Herzuma (trastuzumab-pkrb) for breast cancer indications in December 2018.

Read more about the approval here. 

On January 7th, ASBM Chair Madelaine Feldman, MD FACR was interviewed by the Center for Biosimilars at a forum comprised pharmacists, clinicians, and representatives from biosimilar development companies. The topic was education on biosimilars. Dr Gillian Woollett of Avalere Health moderated the discussion, which was recorded at the group’s studio in New Jersey.
Clips from the interview may be viewed here throughout the month of March.  

APhA Annual Meeting
Seattle, WA – March 22-25

67th WHO INN Consultation

Geneva, Switzerland – April 2-5

BIO International Convention

Philadelphia, PA – June 3-5

DIA Annual Meeting

San Diego, CA – June 23-27