Sep

25

The biopharmaceutical market, estimated to be about $40 billion annually, is one of the fastest-growing segments of the life sciences industry.

When pharmaceutical giants Sandoz (Novartis),  launched Omnitrope, its biosimilar version of human growth hormone (HGH) in Germany two years ago, the price was discounted 20% as compared with Eli Lilly’s Humatrope brand. Also, in Australia biosimilar versions of HGH are sold at a 25% discount as compared with their branded counterparts.

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Aug

5

Israel’s Teva (pronounced teh-vuh) is the world’s biggest generic-drug maker. By making knockoffs faster and in bigger quantities than the competition, the company now accounts for 22% of all generic prescriptions written in the U.S.

Competitors have come out swinging. Swiss drug giant Novartis (NVS) recently won the rights to sell a biogeneric version of Pfizer’s Genotropin, a human growth hormone (HGH), in Japan, and Merck (MRK, Fortune 500) announced plans to develop biogenerics through a division called BioVentures. “Teva is going to be competing with the big boys,” says Sanford Bernstein analyst Ronny Gal.

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Jun

26

ZURICH, June 25 (Reuters) - Japanese regulators approved a human growth hormone from Novartis AG, the first green light in Japan for a biosimilar or generic version of a biotech drug, the Swiss drugmaker said on Thursday

Biosimilars are viewed as a promising new market, given the pent-up demand for cheaper versions of extremely expensive biotech drugs, some of which are coming to the end of their patent life.

Somatropin, made by Novartis’ generics unit Sandoz, is for treatment of growth hormone deficiency in children and growth disturbance associated with Turner’s syndrome or chronic renal insufficiency, the group said.

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May

13

(PhysOrg.com) — A new method developed by Cornell biological engineers offers an efficient way to make proteins for use in medicine or industry without the use of live cells. The proteins made in this way include many that cannot be produced by current biotechnology.

Current methods employ vats of genetically modified bacteria or mammalian cells that churn out proteins for such pharmaceuticals as insulin or human growth hormone (hgh). But there are many proteins that bacteria or cells cannot tolerate. Anti-microbials, for example, are meant to kill bacteria and so would kill the host. And many key proteins that are important in regulating the normal life of a cell would also kill the host if overproduced inside a cell.

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Mar

11

March 10 (Bloomberg) — Momenta Pharmaceuticals Inc. may become the first drugmaker to win U.S. clearance to sell generic versions of a biotechnology medicine, getting a head start on President Barack Obama’s plan to trim health-care costs by making such copycats commonplace.

Brand-name biotech treatments, which can cost individual consumers or their health plans as much as $200,000 a year, are made from living cells, unlike pharmaceutical medicines that are chemical-based. Generic-drug companies can’t sell copies of brand-name biotechnology drugs because the 1984 U.S. law allowing versions of conventional pills doesn’t provide a system to measure safety and approve so-called biogenerics.

Not all drugs made from living cells are considered by the FDA through the agency’s biologics license application process. For a variety of reasons, some categories of treatments made using living cells, including insulin, human growth hormone (hgh) and heparins, were approved under the process for conventional medications.

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Oct

23

A surge in research into novel drug delivery systems will occur as companies seek to differentiate their products in response to pressure from biosimilars, according to a publication from Frost & Sullivan.

The European Medicine Agency’s (EMEA) approval of Sandoz’s biosimilar human growth hormone (HGH), Omnitrope, in 2006, has cut the cost of treatment by 25 per cent. In response to this, Frost & Sullivan recommends that companies should seek to invest in drug delivery technologies to differentiate their products.

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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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