Post Biocon, Pfizer Pushes Forward On Biosimilar MABs

21 May 2012

• By Wendy Diller

Biosimilars pioneers face a steep learning curve and multiple surprises, as shown by Pfizer’s recent and expensive backtrack on its deal with India’s Biocon. But Pfizer says the setback has reaffirmed its strategy as it pushes ahead on its own with a monoclonal antibody program, led by a biosimilar rituximab.

Biosimilars pioneers did not think they were signing on for an easy way to make a quick buck when they entered the field, and recent strategy adjustments by some players confirm the challenges. But so far, no company has signaled that it plans to back off, indicating the beguiling, long-term potential.

A case in point is Pfizer Inc.’s seemingly abrupt breakup in March with Indian biotech Biocon Ltd. over...

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

19 Sep 2024

• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

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16 Sep 2024

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04 Sep 2024

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Brazil Pilots Digital Drug Pack Inserts

18 Jul 2024

• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

Pharma’s Protests Fall Flat As UK Locks In High Rebate Rates

12 Jun 2025

• By Neena Brizmohun

Despite pushback by industry, the government is standing by its new statutory scheme rebate rates for branded medicines, including one that doubles the rate that companies must repay on the sales of newer products to the National Health Service to 31.3%.

EUCOPE Wants Simpler Manufacturing Rules And Framework For Combined Trials Under EU Biotech Act

12 Jun 2025

• By Eliza Slawther

EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.