Making it in America: Post-authorisation challenges for pharma

It is very important to work with experienced US/EU-based regulatory and market intelligence partners.

Diego Ingrassia, senior business development & licensing manager, ELC Group, talks post-authorisation challenges for local pharmaceutical companies.

Many pharmaceutical companies in unregulated markets which are sufficiently large will eventually expand internationally, especially to the United States and European Union. The US and EU remain two of the most lucrative markets for pharmaceutical products, and dossiers approved in these territories are highly sought after due to their high quality compared to dossiers from unregulated markets. A marketing authorisation (MA) approval from the US/ EU can also boost confidence in the products of the companies involved.

However, MA approval is just the first step. There are many steps post-authorisation that require due diligence in order to market the products and maintain the marketing authorisations. To succeed in these highly regulated markets, it is very important to work with experienced US/EU-based regulatory and market intelligence partners who can advise and implement strategies to yield real profit post-authorisation, including – but not limited to – pricing and reimbursement, formation of a network of local distributors, determination of license and supply fee, pharmacovigilance, EU-QC central laboratory management, qualified person (QP) release for each batch, and global life cycle management.

There are many inactive marketing authorisations (MAs) which are available in the market due to a number of factors, including the lack of competitive supply price by the current manufacturer, duplicate products in a company’s product portfolio due to merger and acquisition, and so on. These MAs can be sold to partners outside the EU/US who can provide a competitive supply price. The use of US/EU-approved market authorisations is also a quick method for triggering inspections in non-US/EU manufacturing sites to achieve US/EU-GMP certification, and to start manufacturing and supply to the EU/US.

Partnerships can be established with local companies with interest in high quality dossiers and capabilities to manufacture for the local market, and where local authorities may require local bioequivalence study or local manufacturing. These products can then be marketed as branded generics due to their high quality, and can command a higher price than common generics. In non-regulated markets where counterfeit medicine prevails, there is a high demand of branded generics by consumers.

Licensing is an art in itself, and requires a huge network of contacts, negotiation skills and market intelligence.

A brief process of out-licensing includes: 1) Selection of potential distributors or Marketing Companies (Licensee) interested in establish a long partnership for the commercialisation of the Product in the Territory, on the basis of product (Rx, OTC, Biosimilar), therapeutic indication and target market (EU, US, Russia, China); 2) Introduction of the product to the potential Licensees (scientific, clinical and marketing skill) highlighting the business case of the product in the territory; 3) Receipt of sales forecast from Licensee, prepare market sales projection for the Territory, collect information from the markets (Intelligence activity), and define regulatory strategy.

Bridging the US/EU versus non-regulated market gap requires navigation around many barriers including regulatory requirements, language, culture, and so on, but it can ultimately prove rewarding where both parties can come to a win-win agreement for what would otherwise be an underutilised dossier/MA.