EMA Publish Paper on Revision of Non-Clinical and Clinical Development of Similar Biologicals – Human Insulin
Full Text Here
The current Guidance on Similar Medicinal Products containing Recombinant Human Insulin provides recommendations for the development of recombinant soluble (short-acting) human insulin claimed to be similar to a reference product already authorised in the EU. This guideline came into effect in June 2006 but, so far, no biosimilar insulin has been licensed in the EU. Three products applied for by the same Applicant were withdrawn prior to Opinion.
More recently, several EMA scientific advices on the development of biosimilar insulins, particularly insulin analogues, have been requested. Insulin analogues and long-acting human insulin preparations are currently not covered by the above guideline. In addition, different study populations, study designs and insulin doses have been proposed for the pivotal PD study (clamp study). Moreover, the guideline does not appear to be clear on whether the PK study can be combined with the PD study. Questions were raised regarding the most suitable patient population and size of the clinical safety study. It has also been questioned whether non-clinical studies would always be needed in the development of biosimilar insulins.
Although similar considerations and scientific principles may apply to biosimilar insulin analogues and long-acting human insulin preparations as to soluble insulins, some thoughts may need to be given to the sensitivity of the clamp study for detection of potential differences in the duration of action or other summary measures between long-acting insulin formulations due to the flat PK profile of these insulins and high variability in the tail part of the clamp study. In addition, further considerations regarding the study population (patients with type 1 diabetes versus healthy volunteers), study design (e.g. with
versus without basal insulin infusion) and insulin dose in the clamp study could be included. It may be clarified that the comparative PK evaluation is usually expected to be part of the clamp (PD) study. It
could also be clarified that no formal non-inferiority testing for antibody frequency is expected in the safety study and that inclusion of patients with type 1 and type 2 diabetes may be appropriate. Regarding non-clinical requirements, a risk-based approach may be introduced.
For Assistance with Registering Biosimilar Products Click Here
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
Fill Out the Short Form Below…
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
