After generics slow down in 2013: into biosimilars

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Large pharmaceutical companies are consolidating their generics operations in established markets and/or expanding into emerging ones through local acquisitions or partnerships, writes Ms Doris de Guzman on ICIS website of 10 February 2010.


For example, US-based Pfizer is reportedly in a bidding war against Teva for the acquisition of Germany's Ratiopharm, According to BCC, Ratiopharm held 3% of the global generics market in 2009. Pfizer started increasing its activities in generics in 2009 with an expanded relationship with Indian firm Aurobindo in March 2009 and a commercialisation deal with Indian injectable generics specialist Claris Lifesciences. In January 2010, Pfizer announced a deal with US-based Strides Arcolab to commercialise off-patent sterile injectable and oral products.

"At this point, it looks like Pfizer is really geared up towards expanding more into the generics market," said Mr Doug Long, Vice-President, Industry Relations at IMS Health. Still, not everything is expected to be rosy for the generics market, especially after 2013, when patent expiries will be significantly lower.

"The slowing growth in branded blockbusters being developed by research and development-based manufacturers will ultimately lead to fewer opportunities for generics companies," noted Mr Long. "They are now looking ahead and trying to compete in a less crowded and less competitive market such as in biosimilars."

Federal Trade Commission and EU to follow ‘pay-for-delay’ deals

According to Ms De Guzman, generic and branded pharmaceutical companies are not always at each other's throats. Both US FTC and the European Commission announced their closer scrutiny of the so-called ‘pay-for-delay’ deals, where branded drug companies pay generics firms to delay the market launch of their generic drugs for a certain period of time.

In January 2010, the European Commission asked companies including AstraZeneca, GlaxoSmithKline and Niche Generics, all of UK, Gemany's Boehringer Ingelheim, Novartis and Roche, both Swiss, and France's Sanofi-Aventis to provide information pertaining to generics settlement agreements in Europe between July 2008 and December 2009.

From now on, the Commission also plans to gather this data on an annual basis in the same way as the FTC, which produces annual reports detailing the type and frequency of settlement agreements undertaken by US pharmaceutical companies.

The FTC released a report in January 2010 that claimed that the number of pay-for-delay deals in the US increased from zero in 2004 to a record 19 in 2009. The deals are said to cost consumers US$35 billion (Euros 25 billion) over 10 years. The Commission, meanwhile, estimates that these kinds of deals could have cost European consumers Euros 3 billion (US$4 billion) between 2000 and 2007 (see also Global generics: time for consolidation and expansion and IMS Health, BCC: Generics sales continue to climb)


Tracy Staton. Fast-growing generics ripe for consolidation. FiercePharma. 2010 February 10.

Generic drug sales continue to climb. Pharmagossip. 2010 February 10.

Doris de Guzman. Nonbranded drugs are expected to continue their strong growth. But could the dearth of their new branded rivals cause the sector to hit a wall? ICIS. 2010 February 10.

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