Patent holders are seldom eager to share their recipes and production details for medicines, even after the expiry of the patent. So how does a generics company go about developing our own version of the reference product? While every project is subject to many different variables, there are four key challenges:

• The complex legal situation (patents)
• The high number of molecules and different technologies involved
• The international diversity of the market and regulatory requirements
• Timing

Even if we know the quantitative ingredients or can determine the technology, there is often a lot about the reference product that we simply don’t know. We must develop our own way around the patents using accessible equipment and ingredients in order to prove the efficacy, safety and reproducible quality of our own generic product.

Selecting what products to develop is the job of the Global Portfolio Management group. This team evaluates hundreds of project ideas each year.

Timing is of the essence. Once a project is submitted for development, this process can take an average of five to six years. This includes two to three years of development, and two to three years for the regulatory process.

Why so long? Both innovators and generic companies are increasingly seeking to patent products as early as possible in the development process, over and above basic patents on the single compound. These additional patents often expire at different times to the basic patent, the end of which is generally understood as the starting signal for generic competition.

Active pharmaceutical ingredients (APIs) are the components of a medicine that are pharmaceutically active. Without them, our wide-ranging end product portfolio would not exist.

As in any pharmaceuticals company, a key decision in the development process is whether an API should be purchased or developed in-house. For a company like Sandoz, which is determined to be first to market wherever possible with new medicines, in-house development is increasingly the strategy of choice.

Development of Sandoz APIs is carried out at three sites worldwide: Kundl in Austria, Menges in Slovenia and Kolshet in India.

Obtaining market authorization for a new medicine can be a highly complex process, particularly given the large number of national and international regulatory systems.

In Europe, it is usual to aim for authorization in 10 or more countries simultaneously. It can take two to three years to generate the data for a submission to the regulatory authorities, and the same time again to respond to multiple follow-up information requests and finalize regulatory procedures prior to market launch. 

Away from the relatively harmonized regulatory environment in Europe, authorization can be more complex. In Asia and South America, for example, there are no regional regulatory bodies, and each country is dealt with separately. In some countries there are also few or no patent restrictions, which means generic competition may start soon after the launch of the reference product.

One of our primary goals at Sandoz is to be first to market with new generic medicines following patent expiry. The Development team supports this goal by identifying opportunities and starting projects as early as possible, as well as by efficient processes, technical expertise and good project management.

With more than 900 projects on track at the same time, Sandoz has to set priorities. This can be tricky – it is difficult to cut or consolidate project timelines in urgent cases without jeopardizing the timing of other projects. However, the number one priority is always to get medicines to customers as quickly and as efficiently as possible.