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14 Oct 2018

Generics companies to move away from "little white pills"

Accepting more complexity and risk is key for those generics companies seeking competitive differentiation by diversifying their product portfolios.

In an increasingly competitive market, it is widely accepted that generics companies are facing enormous downward pricing pressure. The mix of new product opportunities is changing, innovators are devising stronger defensive strategies, and the regulatory burden is becoming more expensive.

Drawing from his recent White Paper, "Generics companies, responding to tough times, steer towards higher-risk portfolio strategies", Brandon Boyd of Clarivate Analytics outlined the various portfolio strategies open to generics companies and their uptake to a packed audience at CPHI Worldwide in Madrid. Common to all was a willingness to accept higher levels of risk.

First, serving new channels such as hospitals and even government programs leads to demands on a whole range of factors from packaging through to final documentation. Second, enhancing entry strategies with patent challenges offers the extremely high risk/reward option compared with waiting for patent expiry. Third, moving up the product value chain from oral solids ("little white pills") to injectables and drug-device combinations, while appealing, often requires entering complex partnerships or M&As with all the attached unknowns.

As examples of this he pointed to the case of generic Advair, which still hasn’t been approved despite repeated attempts and generic Copaxone which, while approved with multiple players, still seems a risky area.

So, will generics companies take these risks? The answer according to Boyd appears to be 'yes' – in particular, Indian and Chinese companies are taking some or even all three of the above options. He concluded that meeting the challenge to differentiate will dominate the sector for the foreseeable future and that only those with patience, an unswerving focus on quality and execution will survive.

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