Oct

6

Human growth hormone (hgh; somatropin) was the first therapeutic protein for which a biosimilar version was approved in the US and in Europe in 2006.

There are numerous manufacturers of human growth hormone (hgh) in non-regulated markets, but most of them do not produce in a manner allowing approval in regulated markets although these products are frequently consumed by those interested in gaining muscle mass. Manufacturers in non-regulated markets are also investing in development of next generation human growth hormone (hgh) products and some of them invest in WHO-GMP compliant infrastructure.

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Sep

15

A new form of human growth hormone (hgh) is being used to treat a rare blood disorder:

Teva Pharmaceutical Industries Ltd. yesterday obtained marketing authorization from the European Commission Directorate General for Enterprise and Industry for TevaGrastim, a human granulocyte colony stimulating factor (G-CSF) product. It is a biosimilar product of Neupogen Filgrastim, a recombinant DNA treatment for chemotherapy-induced neutropenia (a blood disorder) made by Amgen Inc.

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Jul

10

Manufacturing of biopharmaceuticals is in the news once again:

The consolidation process in the biogenerics industry has commenced after first approvals of biogeneric human growth hormone (hgh) products in the US and the EU and first filings of biogeneric erythropoietin and insulin in the EU. Smaller biogeneric companies have been taken over by generic players from India and Eastern Europe.

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May

29

 Biosimilair versions of HGH recently received approval in Europe.

LONDON - With the first generic biologics reaching the market in Europe, the focus has shifted from arguments about how to approve them, to how the products should be used in clinical practice.

Rather than biogenerics, the European Medicines Agency (EMEA) has tagged the products as biosimilars. The explicit recognition that they are not exactly the same as the originator product is raising issues of substitutability and pharmacovigilance.

Two biosimilar versions of erythropoietin (EPO) and two of somatrophin (human growth hormone) have been approved, a G-CSF biogeneric is about to get the nod and there will be many more products on the market in the next five years, making it essential that processes are in place to ensure their safe and appropriate use.

 

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