Who doesn’t like a good story, especially when it has a happy ending? That’s the case of this 4TE story, where we helped a company with their biosimilar product approval.
So, fasten your seatbelts and join us in finding out how we helped a company avoid massive time-to-market delays and other losses!
Let’s know what happened!
Our story starts with the regulatory authorities requesting additional clinical studies to a company. The company had done and submitted already all the regular similarity exercises and, due to this request, they would have to repeat them all over again.
The problem: as you know, these similarity exercises are complicated and time-consuming and could compromise the product’s time-to-market with 2 to 3 years of delay.
Of one thing
, we were sure. If this company use the same methodology, they would be under a lot of pressure to obtain that marketing authorisation. It was time for us to get into action!
How did we help the company in their biosimilarity assessments?
Like we said, our client’s deadlines and product market performance were at risk, so we needed to act quickly!
We thought the most effective approach would be through an integrated multi-parameter and multivariate strategy. We decided that because it allowed us to extensively compare the total domains of the biosimilar and the reference product.
So, we started by comparing the whole analytical domains for all bioanalytical techniques used for both biosimilar and reference products. Then, we ensured that the minor changes detected did not affect the identity, strength, quality, purity, or potency of the product and, as a result, its safety or efficacy.
And did the company benefit from our intervention?
We already gave away it was a happy ending, didn’t we?
The company received an approval for their biosimilar product and, by integrating a multi-parameter and a multivariate strategy, no further clinical studies were required.
More than having a complete characterisation of the whole analytical domain of biosimilar products, this approach demonstrated the high similarity between the biosimilar and the reference product.
Also, by implementing this strategy, we could mitigate the initial residual uncertainty. And, the best of all, the company managed to achieve a strategic position in the market!
Your process can be a success story too!
Our team gives you all the support when it comes to approving biosimilar products. We ensure that your processes continue to provide the final product’s quality, safety, and efficacy. .
If you think we may be able to help you out, don’t hesitate to book a call. We’ll do our absolute best to help.
If you would like to know more about the approval of biosimilars and comparability studies, we’ve got the perfect readings for you in our blog. Just check it!