Clinical Development

“Clinical trial success is the key to confirming biosimilarity for biosimilars and making them available for a large patient population”

Karsten Roth, Director Clinical Research and Development

Our clinical development and operations group plan and manages pre-clinical and clinical trials from phase 1 to phase 3. These include first -in-man, PK/PD trials and international multicentre phase 3 trials in various indications. Designing clinical trials for biosimilar in close alignment with regulatory agencies is critical and sensitive tool to confirm the biosimilarity of our products to the originator and to ensure that the products are safe for the patients that need them most.

Clinical trials for biosimilars

Clinical trials for biosimilars are indeed comparative clinical studies. The essence of the study is to compare the original drug with a biosimilar drug candidate. Consequently biosimilar clinical trials focuses predominantly on confirmation that the biosimilar drug candidate clinically equivalent with the originator in terms of pharmacokinetics, pharmacodynamics, clinical safety, clinical immunogenicity and efficacy. While requirements vary by regulatory agencies at least one clinical trial is required.

Once biosimilarity is confirmed, regulators may allow extrapolation to other licensed bio-originator indications, provided efficacy relies on a similar mechanism of action in each one. Consequently, a biosimilar may be approved in all indications for which the bio-originator has been approved, without multiple clinical trials.

Our clinical trials

Clinical trials are a huge operation, involving multiple global teams, various vendors, and are logistical challenges. Our clinical development and operations team has decades of experience of planning, overseeing and managing all aspects of clinical trials to maximise the chances of a positive outcome and completion in the anticipated timeframe to support our biosimilar developments.

The clinical teams are embedded in our business to provide advice, strategy, and execution of pre-clinical and clinical trials, they work closely with our technical development, manufacturing, project management and regulatory affairs team. Such approach ensures the building of a unified professional team-knowledge on a biosimilar product in a specific therapeutic area.

Clinical trial management

We oversee clinical trials from the pilot and early feasibility studies including first in human to multicentre, global phase III studies, independent of whether these are following standard clinical endpoints or sophisticated adaptive designs.

Develop clinical trial designs tailored to research goals
Design clinical development strategies such as set up and review clinical protocols including:
- Determine sample size calculations and target populations
- Blinding strategies and placebos selection
- Site and investigator selection
- Biodistribution
Management of timelines, budget, deliverables and data quality
Ensuring efficient communication with sponsor, vendor and sites
Report writing and reviews for submission

Polpharma Biologics clinical trials

For more information on clinical trials run by or sponsored by Polpharma Biologics please view the clinicaltrials.gov database. You can view the progress of our biosimilars on our Pipeline page.