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Development of Bio-similar Strategy

Safeguard the position

A well-regarded, high-quality originator product of a pharmaceutical company was facing the challenge of mid-term entry by bio-similar products. The company asked Vintura to help. Given the critical product characteristics, the company wanted to protect the good reputation of the class in terms of quality, and in doing so also safeguard the position of its own brand.

 

Overview of critical points

We made an inventory of the critical production and product characteristics with respect to consistent health outcomes and patient safety. The emphasis was on past product issues and challenges. We drew up an overview of the critical points that required attention. These points were translated into draft regulatory guidelines (both for production and for the product itself) for the purposes of registering bio-similars within the same class. These guidelines were then proposed to the authorities.

 

Brand continued to grow

Based on our clear approach and disciplined process used, the regulatory guidelines were accepted and implemented by the authorities in order to ensure sustained patient safety, and the positive perception of the class and brand was also safeguarded. As a result, the brand continued to grow, even after the loss of exclusivity.