Safe Biologics

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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

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