Competitor review

The review of competitors’ products can be vital for formulating the strategy of a Marketing Authorisation (MA) and can be essential for establishing a viable marketing strategy and pricing. Assessing the needs and demands of patients and consumers can also provide the information to accurately predict sales and returns. In addition, there is always a requirement to be a competitive market player especially within the pharmaceutical sector.

Competitor review is not a one-time analysis but is necessary during all stages of development to ensure successful commercialisation of a medicinal product. A competitor review should include efficient collection and analysis of competitor information to support a successful regulatory strategy from development through to post-marketing. The analysis of competitor information may be challenging for organisations due to regulatory complexity and the vast amount of information  available.
While conducting a competitor review, it is important that an organisation is aligned with legal and ethical requirements while collecting and using the acquired information. Since the pharmaceutical industry is highly regulated it is important to ensure that any competitive intelligence is collected and used ethically. Adherence to national, international trade and competition laws is also necessary when performing a competitor review.

During early stage development, a competitor review should include current and accurate information on the status of a competitor’s portfolio. Additionally, any new competitor medicinal products on the market should also be identified.
Competitor review during clinical or late stage development should include continued surveillance of the competitor’s products and changes in regulations for specific products or therapeutic areas. This is particularly important for novel therapies or advanced therapy medicinal products where regulations may not be clear or well established. Regulatory expertise and intelligence should therefore be an integral part of a competitor review to interpret these regulations.
Reviewing and monitoring of publicly available clinical study information to establish the need for a post-marketing trial or access in cases of unmet medical need helps strategising the potential establishment of Early Access Programmes, which should also be considered during a competitor review.
After marketing a medicinal product, a review of any changes to a competitor’s MA needs to be conducted regularly. For pharmaceutical companies marketing generic medicinal products, it is important to be aware of any changes to the MA of the reference medicinal product. For example, safety changes to the Product Information of the reference medicinal product will also need to be considered for the generic MA.
Competitor review should consider changes that might be subject to patent protection or market data exclusivity protection. Tracking the duration of any protection of competitor products can provide valuable information.