Labeling Survey Released as FDA Makes First Approval 

On March 23, ASBM Executive Director Michael Reilly, presented at “The State of Autoimmune Disease: a National Summit” held at the National Press Club and hosted by the American Autoimmune Related Diseases Association. During his presentation, he released the findings from ASBM’s new biosimilar labeling survey that reveals that physicians who prescribe biologics support transparent, clear labels with data that enables prescribers to learn about and evaluate the medicines available to their patients.

Read more on the survey here.

ASBM to Participate in WHO Naming Meeting

On April 13, ASBM Chairman Dr. Harry Gewanter and Advisory Board Chair Dr. Philip Schneider, will participate in the World Health Organization’s (WHO) 60th International Consultation on Nonproprietary Names in Geneva. Dr. Gewanter and Dr. Schneider will attend the INN meeting to offer support for the WHO’s Biological Qualifier (BQ) proposal. 

CE Class on Biosimilars for Pharmacists

On March 15, ASBM held a five-hour continuing education (CE) class offered through the Long Island University (LIU Pharmacy) to educate pharmacists on biosimilars. The class,”The Fundamentals of Biosimilars: What Every Pharmacist Will Need to Know,” was held at the New York LaGuardia Airport Marriott and explained what biologics and biosimilars are, how they are manufactured and regulatory challenges associated with them.

The class discussed the basic science and manufacturing of biologic medicines; the clinical implications of the key features of biologics size, complexity, sensitivity/propensity for change that distinguish biologic medicines from chemical drugs; their difference from generic drugs for purposes of patient care, pharmacovigilance, and pharmacy practice; and the important regulatory and policy considerations – that many state capitals are currently legislating across the country. Over 150 pharmacists attended the class and ASBM plans to host more classes like this throughout the country over the coming months.

Read more on the class here.

ASBM Presents Canadian Survey Results in BIOTECanada Webinar 

On March 31, Executive Director Michael Reilly, participated in a webinar hosted by BIOTECanada to share the results of the Canadian Physician Survey on SEBs. The webinar briefed patient group representatives on the results of the survey and discussed common misconceptions about SEBs, in addition to the need for a distinguishable naming scheme for all biologics, including SEBs.

View the presentation here. 

In the States

California

The Senate Business, Professions and Economic Development Committee will hold a hearing on April 13 at 1:00pm on SB 671.

Colorado

On April 6, Governor John Hickenlooper signed SB 71 into law. 

Georgia
SB 51 and HB 195 have been introduced in Georgia with communication language and hearings are expected to be held soon.

Maryland

Biosimilar bills are pending in Annapolis with only one week before the legislature adjourns. The House Committee on Health and Government Operations held a hearing on April 2 on SB 537.

North Carolina

The Senate took up the version of SB 197 that had been passed by the House last week. The bill passed the 1st reading in the Senate, and was referred to Senate Committee on Rules and Operations.

Tennessee

The House and Senate rescheduled when the bill would come to the floor in each chamber last week. SB 984 was on the Senate Calendar for April 6 and passed the Senate as amended, and HB 572 is on the House Calendar for April 8. 

Texas

Letters of support are needed in Austin for SB 542 and HB 751 that require communication with prescriber within a “reasonable time” after dispensing.

Utah

Governor Gary Herbert signed HB 279 into law last week.

Washington

The House referred SB 5935 to the Appropriations Committee.

Upcoming Conferences:

• April 13-15: WHO 60th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland
• April 20-21: 2015 FDLI Annual Conference in Washington, DC 
• April 23-24: 13th EGA- European Biosimilars Group Conference in London, England
• May 27-28: World Biosimilar Congress USA in San Diego, CA
• June 14-18: DIA 2015 51st Annual Meeting in Washington, DC