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On January 24th, 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. 

ASBM was represented at the Midyear Meeting by its Advisory Board Chair, Philip Schneider, MS, FASHP, FFIP; who is a past president of ASHP.

At ASBM’s booth, Schneider and ASBM staff distributed information to attendees regarding key biosimilar policy issues which affect pharmacy practice. These include biosimilar approval, biosimilar naming, substitution policy at the state level, and the non-medical switching of patients’ biologic medicines by payers.

Educational videos targeted at pharmacists were also shown at the ASBM booth during the three-day exhibition. These included a video featuring Schneider and fellow ASBM Advisory Board member Ron Jordan, Dean of the Chapman University College of Pharmacy and past president of the American Pharmacist Association (APhA). ASBM’s recently-released pharmacist videos on naming, interchangeability and substitution, and non-medical switching were also shown.

Read more about the ASHP Midyear Meeting here. 

In mid-November, ASBM released three videos in which pharmacists discussed key biosimilar policy issues. The videos featured ASBM Advisory Board Chair Philip Schneider, MS FASHP; Professor at Ohio State University College of Pharmacy, and past president of the American Society of Health-system Pharmacists. Professor Schneider is joined by Chapman University School of Pharmacy’s Professor Daniel Tomaszewki, PhD, PharmD; a frequent participant in ASBM’s Continuing Education courses for pharmacists.

• The first video is entitled “Pharmacists and Biologic Naming” and may be viewed here.
• The second video is entitiled “Pharmacists and Biosimilar Subsitution” and may be viewed here.
• The third video is entitled “Pharmacists and Non-Medical Switching” and may be viewed here.

FDA Approves 15th Biosimilar, First for Treatment of Non-Hodgkins Lymphoma

On November 28th, the U.S. Food and Drug Administration (FDA) approved Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy. Truxima is the first biosimiliar to be approved in the U.S. for the treatment of non-Hodgkin’s lymphoma.

With the Truxima approval, the FDA has approved 15 biosimiliars.

Read the FDA’s press release about the approval here. 

On Nov. 2, 2018, the FDA approved Udenyca (pegfilgrastim-cbqv) from Coherus, as the second biosimilar to Neulasta (pegfilgrastim). The first, Fulphila (pegfilgrastim-jmdb) was approved by the FDA in June 2018.

Like their reference product, the biosimilars are used to decrease the chance of infection as suggested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells), in patients with non-myeloid (non-bone marrow) cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia.

Read more about the approval here.

On November 2nd, 2018, GaBI Journal published an article by Former FDA Associate Commissioner, Peter J. Pitts and ASBM Executive Director Michael Reilly, entitled “Medicines regulation in the MENA region and the importance of the World Health Organization’s INN proposal of Biological Qualifier”.

The article examines the safety and pharmacovigilance benefits the WHO’s BQ proposal would bring to Middle Eastern and North African countries if and when it were to be made available. From the abstract:

When it comes to monitoring the quality, safety and efficacy of biological medicines, distinguishable naming is imperative because biosimilar therapies are similar to, but not exactly the same as, existing biological medicines. Since no biosimilar is perfectly identical to its innovator parent, every biological – whether reference product or biosimilar – must be fully distinguishable from other biologicals to permit quick and accurate tracing of its manufacturer, should an adverse event be observed. Precise naming of all biologicals will improve patient safety by reducing confusion and mishaps in prescribing and holding manufacturers accountable. Also, differential nomenclature helps enable national health authorities to collect and compare real-world data that measure the clinical effects of biologicals including biosimilars. Insights from such data, over time, will enable us to better measure a drug’s effectiveness in delivering successful health outcomes for patients.The World Health Organization (WHO) must finalize their Biologic Qualifier guidance. It is this organization that has the responsibility to ensure that developing nations of the world have access to affordable, quality medicines. Safety is mission critical and the Biological Qualifier is a potent tool on behalf of global public health.

The article will also be published in GaBI Journal’s next print edition.
Read the full article here.

APhA Annual Meeting
Seattle, WA – March 22-25, 2019

DIA Annual Meeting

San Diego, CA – June 23-27, 2019