Synergy Satellite: Evidence and pharmacovigilance of monoclonal antibody reference and biosimilar products

 

 

Prof. Dr. Håkan Mellstedt: “Monoclonal antibody biosimilars: robustness of products vs. clinical experience.”

 

 

Monoclonal antibodies play a prominent role today in the treatment of severe and chronic diseases e.g. in cancer patients and patients with autoimmune diseases. Moreover numerous innovative monoclonal antibody products are under development. As monoclonal antibodies (mAb) are highly sophisticated medicinal products, the development, biotechnology enabled production, formulation; quality control and use in clinical practice pose challenges on all the parties involved. Costs for the mAb products pose financial challenges on the health care systems. Of note, biosimilar mAbs are approved by the European Medicine Agency (EMA). Although EMA has issued specific guidelines that define the regulation of biosimilar mAbs in Europe the resulting opportunities are combined with specific challenges. The discussions among healthcare professionals about mAbs relate to the pharmaceutical quality, safety (especially immunogenicity), efficacy (particularly in extrapolated indications), and interchangeability with the originator products. In the hospital additional questions regarding the assessment of biosimilars for hospital formulary inclusion, naming, substitution and pharmacovigilance measures are to be answered. The granting of approval does not mean that the biosimilar product can be automatically substituted for the reference product and vice versa. For suspected adverse reactions the traceability and definite identification of the concerned product is of particular importance. Therefore appropriate measures should be taken to identify clearly any mAb product with due regard to the name and the batch number. Extrapolated indications are in general linked to more comprehensive post marketing commitments and this will be a critical issue in mAbs with Fc related pharmacological activities. Total costs need to be calculated and economic decisions made according to local pricing and reimbursement regulations. Members of the hospital’s drug and therapeutics committees have to discuss these questions and the practical implications prior to the decision-making. Physicians, pharmacists and other healthcare professionals in the hospital needto be educated regarding the decisions and underlying information as well as practice issues, especially prescribing, naming, interchangeability and documentation. Furthermore there is a need for communication between healthcare professionals, regulators from the licensing and naming authorities, and the marketing authorisation holders to improve the safe use of mAbs in patients. During this seminar the communication will start and mAb therapy will be highlighted from different perspectives.

 

• To improve the knowledge about monoclonal antibody drug products regarding quality, efficacy, safety, and pharmacovigilance issues; 
• To understand the specific challenges of biosimilar monoclonal antibodies; 
• To discuss opportunities and challenges of monoclonal antibodies reference and bio-similar products.

 

After the presentation the participants should:

 

• know the different mechanisms of action of monoclonal antibodies;
• know the EMA regulations for licensing monoclonal antibody reference and biosimilar products including naming, and interchangeability;
• be able to understand the EPARs of monoclonal antibody drug products and to communicate the information to other healthcare professionals in the hospital;
• be able to evaluate the quality, efficacy and safety of monoclonal antibodies to be added to the hospital drug formulary;
• be familiar with pharmacovigilance measures of monoclonal antibodies and be able to put them into practice in the hospital.