March 8, 2006
Biogeneric Human Growth Hormone

It is expected the human growth hormone biogenerics will be able to enter the UK by the end of this year, and in the United States by 2009.

The global market for biogenerics such as human growth hormone, CSF, and Epoeting, are expected to reach over $20 Billion.

The companies that are responsible for introduction of biogenerics include big names such as Sandoz, Teva, and BioPartners. With their introduction into UK society, the biogeneric companies will be subjected to a regulatory process for the 25 biogeneric companies. The FDA is expected to approve the use of its first biogeneric product in 2009, with the hopeful introduction of biogeneric insulin and growth hormone.

However, the introduction of biogenerics, the general public will require a different type of marketing strategy that was previously used. The strategy will need to focus more on gaining the patient’s trust and support while trying to help consumers see the advantages of using a biogeneric product.



December 13, 2005
Iplex Approved By FDA

Insmed, Inc announced yesterday that the FDA had approved the use of the drug Iplex that it manufactures. Iplex is indicated for treating children with growth problems.

The drug will not be released until late 2006, but it will be used to treat children with a severe primary IGF-1 deficiency or deletion of the Growth Hormone gene.

The release of Insmed’s Iplex comes after Tecica Inc announced in late summer that the FDA had approved the use of its drug Increlex for treatment of IGF deficiency as well.



December 10, 2005
Tercica Announces Submission Of Marketing Application

Tercica announced submission of Marketing Application to the European Agency For Evaluation of Medicinal Products, for the right to sell Increlex in the European Union.

The FDA approved the use of Increlex ™ last August. It is primarily for use in people suffering from Primary Insulin Growth Factor Deficiency (IGFD) or Growth Hormone Gene Deletion.

Increlex ™ is the synthetic version of the hormone IGF, which is released in response to stimulation by Growth Hormone. By giving Increlex™ to children deficient in IGF, the, they should be able to increase in height.