With almost three decades of recombinant protein production experience, Novartis is now seeing its work paying off as its biosimilars grew by 23% over the same quarter last year to $420m (€310.5m) in Q2.
The climate for biomanufacturing has changed according to Pfizer, which has set out to win more contracting work for its hormone plant in Sweden and says it will even consider making large molecule drugs for Big Pharma rivals.
Spurred on by the frustration of drug manufacturers, governors from
four US states have petitioned the US Food and Drug Administration
(FDA) for clarity in their requirements for the production of
generic versions of insulin and human...
Swiss biopharmaceutical firm Biopartners has got the thumbs up from
the European Commission for its biosimilar drug Valtropin, making
it only the second biogeneric drug to have been approved in Europe
after Sandoz's Omnitrope...
Regulatory obstacles to the development of the market for
biogeneric drugs are falling down, and the first products are set
to reach the markets of North America and Europe in 2006-7,
according to consulting firm Frost & Sullivan.
Switzerland-based BioPartners has submitted a second Marketing
Authorisation Application in Europe for a generic copy of a
biologic drug under the recently agreed European Union framework
for so-called 'biosimilar' drugs.
Representatives of the pharmaceutical and biotechnology industries
presented strong opposition to the concept of biogenerics at a
recent meeting convened by the US Food and Drug Administration. As
expected, their argument centred...