Sandoz sued FDA in its effort to win approval of Omnitrope (somatropin [rDNA origin]). Now the company is using more mundane regulatory procedures as it works to expand sales of its follow-on human growth hormone.

The company received approval for a new formulation of the drug, Omnitrope Pen 5 with liquid cartridge, on January 16, and Sandoz is hopeful the new version will help it overcome the barriers to acceptance that the original, lyophilized powder version faced.

The new form of Omnitrope will be released shortly in the U.S. (it was released in Europe in April 2006) and carries the same indication as the original version: for long-term treatment of pediatric patients who have growth failure and long-term replacement therapy in adults with growth hormone deficiency.

Omnitrope was approved in the U.S. in May 2006, and appeared on the market last January as a lyophilized powder form administered by pen injection. Referencing Pfizer's Genotropin , Omnitrope was the first follow-on version of a human growth hormone product approved under the 505(b)(2) pathway (¹ Also see "FDA Clears Omnitrope; Product Is Not The Process, But Nor Is It A Pathway" - Pink Sheet, 5 June, 2006.).

At a Food and Drug Law Institute conference last November, Omnitrope was criticized for leading to a low generic substitution rate due to its delivery system (² Also see "Omnitrope’s Low Switch Rate Due To Inferior Delivery Device - Express Scripts" - Pink Sheet, 26 November, 2007., p. 12).

Express Scripts chief medical officer Steven Miller said the drug "doesn't cut it" and described it as "not competitive." At the meeting he urged Sandoz to look at the efforts that companies like Genentech put into designing their delivery systems, and pointed out the difficulty of giving children injections every day.

A Test For Biosimilars

Sandoz was already at work on the new version of the product - more than a year before - but the public criticism emphasized the frustrating promise that follow-on biologics offer to payers.

Insurance companies and generic firms do not expect the follow-on biologics market (if and when a pathway for product approval is created) to function like the small-molecule generic market does now, with nearly instantaneous and total substitution. And Omnitrope, which is not AB rated and competes in a category which already has several products, may not be the best test case for how follow-ons will be accepted.

The effort to create a new delivery system, however, shows that firms will face more than regulatory hurdles as they bring their follow-ons to market.

While the original Omnitrope formulation offered "some incremental savings, the burden you were putting on the family to prepare and administer the drug, really resulted in most of our clients not wanting to prefer this product," said Miller in an interview with "The Pink Sheet."

In order to administer the original formulation, the powder must be mixed with bacteriostatic water which is supplied with the drug.

"They have gone the next step and gotten themselves what we believe is going to be a competitive delivery system," said Miller, who noted Express Scripts has already created a program to support the new drug. "We actually think this will represent a great opportunity for clients who are interested in saving in this category."

Sandoz could not agree more. "We think that the new product will have more appeal to people," said Sandoz spokesman Charles Bruns. "It's an easier system to use: the pen with the liquid cartridges. It won't involve the extra step of going from a powder to then making it an injectable."

"We think that they both are interchangeable, and we think that there is going to be more interest with the liquid cartridge," said Bruns. "It's an improved delivery system and we think it will make the product more appealing to more patients."

While neither Sandoz nor Express Scripts would comment on the price of the Omnitrope Pen 5, Miller said "there will be a price advantage for the patient and the client" and the new delivery system "will truly be a very price competitive product."

"This is really a move in the right direction," said Miller. "The big issue has always been: will biosimilars be able to make a difference, or will you have to have true bio-generics? We believe we're in a position to make biosimilars work for the market place. This is going to be a great case proof for that."

- Lauren Smith (Lauren.smith@elsevier.com)

Omnitrope’s Improved Delivery System Already Getting Formulary Traction

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