The competition to be the first generic on the market after patent expiry is fierce. Achieving that coveted number one slot is preceded by many years of development work and negotiation with regulatory authorities, and also involves an intricate journey through the complicated patent network.
We have built a comprehensive global production and development network with competence centers in all major markets in order to expand our activities beyond standard generics and to promote innovation. Spending on development has increased consistently over the years and, with more than 800 development projects in the pipeline, we have one of the richest pipelines in the industry.
In addition to generics, our expertise in biotechnology enables us to develop and produce complex and cost-effective biopharmaceutical medicines, like biosimilars. With worldwide demand for these products increasing steadily, we are proud that Sandoz is the pioneer and global leader in the field of biosimilars.
Generics Development: What is so difficult about copying a product that already exists?
A common misperception is that innovators simply share their product 'recipes' with specific details about the active ingredients and production processes. Patent holders are seldom eager to share this information, even after the patent has expired. Data regarding the original reference product is in fact never revealed to third parties, and as such not used in generic applications.
So how does a generics company go about developing its own version of a reference product? While every project is subject to many different variables, there are four key challenges encountered during this development process:
- The complex legal situation surrounding intellectual property (IP);
- The high number of molecules and different technologies involved;
- The diversity of international markets and regulatory requirements; and Timing.
Knowing the quantitative ingredients or determining the technology involved is not sufficient, as much about the reference product remains unknown. Formulation or synthesis processes may be different, while the equipment and type of ingredients could be unique or their use protected by additional patents. As a result, generics must develop novel, non-infringing ways of formulating or synthesizing the product using accessible equipment and ingredients that prove their safety, efficacy and reproductive quality.
Product Selection: When the development process truly begins
The first step of the generics development process starts at the very beginning of the value chain, with product selection. In the generics industry, timing is of the essence as once a project is submitted for development, it can take an average of five to six years before the product reaches the market. This process typically includes two to three years for development in addition to two to three years for regulatory approval. As generic products increase in their level of complexity and sophistication, however, this development process can be extend even further.
Although the expiry of a compound’s basic patent is generally understood as the starting signal for generic competition, both innovators and generic companies are increasingly seeking to patent their products, formulations and processes throughout the development process, in order to create greater barriers to generic entry. As a result, generic companies need to be innovative in the product development process by using novel methods, formulations and processes that are not in infringement of any existing intellectual property.
APIs: Securing Access to Basic Ingredients
An active pharmaceutical ingredient (API) is the substance in a drug that is pharmaceutically active and which has a targeted therapeutic effect in the body. Finding and securing API that meets various regulatory requirements, such as for purity and stability, and that is not in infringement of intellectual property, is a critical step in the development process that can often take considerable time, and tend to start at least one year ahead of finished dosage form development.
A key decision at the start of the development process is whether an API should be developed in-house or sourced from a third-party supplier. This is a strategic decision that depends on a number of key factors such as the number of quality market suppliers, the patent landscape surrounding the active compound, cost competitiveness and/or the technological complexity of its formulation. Such factors are closely looked at and assessed in Sandoz’ selective and targeted approach to vertical integration.
Authorization: a Highly Complex Issue
Obtaining market authorization for a new medicine can be a highly complex process, particularly given the large number of worldwide regulatory authorities involved. In the European Union, for example, companies tend to seek approval in 10 or more countries simultaneously through the Mutual Recognition (MRP) and Decentralized Procedures, led by a selected Reference Member State. It often takes two to three years to generate the data for a submission to the regulatory authorities, and a further two to three to respond to their follow-up information requests and finalize regulatory procedures.
Away from the relatively harmonized regulatory environment in Europe, authorization is often more complex in other parts of the world. For many markets, such as in Asia or South America for example, no international regulatory authority exists that coordinates the local authorities in each country and harmonizes there respective processes. As a result, each country is dealt with individually, which compounds the level of effort and work involved. In other countries, there are few or even no patent restrictions, allowing generic competition to start soon after the launch of the reference product by the innovator company.
First-to-Market: Securing Access to Medicines
Speed and being first-to-market with new generic medicines is a key success factor for Sandoz. Next to bringing patients new affordable treatments as quickly as possible, launching ahead of our competition allows us to increase worldwide access to high-quality medicines, while securing market share and further strengthening our global leadership position. As a result, our teams work diligently to identify opportunities and anticipate future needs as early in the development process as possible, in order to always deliver medicines to customers as quickly and as efficiently as possible.