Sandoz wades deeper into generic biopharmaceuticals
By Kirsty Barnes
16/10/2006 - As it looks to the "future of pharmaceuticals," Sandoz is planning a "powerful biopharmaceuticals programme" with the construction of a new biopharmaceuticals development centre in Ljubljana, Slovenia.
The new €6.7m facility will develop and manufacture generic biopharmaceuticals for Novartis-owned Sandoz's global markets, through its Slovenian generic drug making subsidy, Lek.
“By building this structure we are taking a major step into biopharmaceuticals – the technology of the future in pharmacy,” said Janja Bratoš, president of the Lek board of management.
“This field has an exceptional amount of potential, with the highest growth rate, and it promises a very interesting future, so we are clearly going to follow this path,” said Mateja Urlep, head of Biopharmaceuticals at Lek.
Biopharmaceuticals, or biological medicines, are drugs which are produced using recombinant DNA technology on the basis of human proteins (e.g. hormones, insulins, antibodies etc.)
The biopharmaceuticals market has undergone rapid expansion since its emergence thirty years ago and innovative science in this field, driven by the 2001 human genome project, is accelerating the market into targeting a huge range of diseases from growth deficiency to arthritis to multiple sclerosis and orphan diseases such as Fabry's disease.
As a result, market analysts Visiongain valued the biopharma market at $70.8bn (€57bn) in 2005 and predict it to display double-digit growth until the end of the decade.
“The market by 2010 is expected to represent 17 per cent of all prescriptions written, compared with 2004's 12 per cent. At this pace of growth, biotech is now outgrowing Big Pharma,” said a recent report by the firm.
Meanwhile, a barrage of older-generation pharmaceuticals, with a total value of $20.2bn in global sales, such as insulin, human growth factor (hGH), epoetin, colony stimulating factors, interferon alpha and interferon beta have come off patent and are all now susceptible to competition from biogenerics manufacturers.
Although the Food and Drug Administration (FDA) has so far been reluctant to approve many copycat biologics because of the challenges that the sophisticated manufacturing processes pose and the significant regulatory hurdles they present, the regulator has been facing increasing pressure from many in the industry to clarify its requirements for the production of such drugs and thus “open the floodgates” to generic competition.
This will only be a matter of time.
In anticipation, Lek opened its first manufacturing plant for generic recombinant products at the site in Ljubljana in February 2004 - the first manufacturing plant for recombinant technology in Slovenia.
“The latest development complements this activity, forming a centre of excellence for cell culture technology in our global Biopharmaceuticals organisation,” said Dr Andreas Rummelt, Sandoz CEO.
Completion of the 2,800m2 building, which will employ 100 professionals from the fields of microbiology, biology, biochemistry, chemistry and pharmacy, is expected mid-2007.