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Generics outfit Sandoz has achieved another milestone with the approval of Omnitrope in Canada. On April 20th 2009, Health Canada granted a Notice of Compliance for Omnitrope, making it the first Subsequent Entry Biologic (SEB) to be approved for sale in Canada. For those unfamiliar with the lingo, SEB is the regulatory term used by Health Canada equivalent to "Biosimilars" in Europe or "Follow on Biologics" in the USA.

Omnitrope, a somatropin (rDNA origin) for injection, is approved for the long-term treatment of children with growth failure due to an inadequate secretion of endogenous growth hormone, and long-term replacement therapy in adults with growth hormone deficiency due to an underlying hypothalamic or pituitary disease or who were growth deficient during childhood. With this authorization, Omnitrope carries the reputation of becoming the first biogeneric product to be approved in Europe, USA & Canada. The market authorization was based on quality, non-clinical, and clinical information submitted. Details about the studies found here.

Whilst the debate over cost savings versus quality continues to intensify between regulatory bodies and law makers, it is encouraging to see products trickling through a system whose effectiveness cannot be evaluated unless it is put into practice. , the current system (however skeletal it may be) needs to be tested in order to:
1)Define the parameters of substitution of biosimilars for innovator products;

2)Determine the extent of pre-clinical studies & clinical trials required to demonstrate safety and comparability;

3)See whether true copies of biologics can be made despite the original products being covered by extensive trade secrets, patents and proprietary technologies;

4) Test the financial sustainability of biogeneric manufacturers. The development of each biogeneric product will be a lengthy, complex process, and is projected to cost about $200 million, compared to approximately $30 million for a traditional generic drug;

5) Quantify the extent of cost savings and the impact of competition on cost reduction;

6) Gauge consumer confidence and acceptance.

It is clear that regulations for biosimilars or follow-on biologics will be implemented in the near future. However, What remains to be seen is whether political pressure from influential groups and an extremely cautious approach on the part of the legislators can be balanced out to develop a functional pathway to approval.

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Preemption: What is it good for?

For more than a decade, drug manufacturers in the US have been inadvertently protected from product liability claims thanks to preemption - the precedence of federal law over that of state law.

So what happens when a patient takes a generic version of a drug that results in an adverse event (or death) due to inadequate warnings? Surely the consumer is protected by being able to sue the manufacturer, correct? Apparently not. Generic manufacturers have successfully argued that they were unable to provide sufficient warning as their labels are required to be the same as the labeling approved for the original innovators drug. Additionally, a generic drug manufacturer may not unilaterally strengthen a label without prior approval of the FDA. Therefore, it "would be impossible" for the manufacturers to abide by federal law requiring that the generic have the same label as the innovator and the state-law requirements for stronger warnings. Surely then the onus falls on the innovator companies for not originally having sufficient warnings, correct? The uninformed patient may be shocked to learn that most state courts have ruled that the name-brand manufacturers could not be held liable for injuries caused by another manufacturer's product.

This is the conundrum posed by preemption. Preemption prevents plaintiffs from pursuing their claims against defendants whom they allege caused their injuries, and yet the preemption doctrine is based on a choice of the superior method for regulation. The distinct lack of a legal remedy in such cases may explain the California Court of Appeal's decision in Conte v. Wyeth.

In Conte v. Wyeth, Elizabeth Conte alleged she developed an irreversible neurological condition after long-term use of generic versions of Wyeth’s Reglan. Although she only took the generic version of the drug, she argued that Wyeth negligently misrepresented the serious risks associated with long-term use of the brand-name version of the drug and should be held liable. Conte filed a lawsuit against Wyeth as well as generic manufacturers Purepac, Teva, and Pliva. After obtaining summary judgement in trial court, Wyeth & the generic manufacturers succesfully argued that Wyeth's product information had no causal relationship to Conte’s injuries and the Conte's claims against the generics were preempted under the Food, Drug and Cosmetic Act.
The California Court of Appeals, First Appellate District, reversed in part and reinstated Conte’s action against Wyeth. Ignoring decades of products liability precedent, the Court concluded Conte could proceed against Wyeth on her negligent misrepresentation claim on the basis of common law.

Preemption is a classic example of instances where enforcing an optimal regulatory strategy does not necessarily translate into protection of the public. In the search for a one size fits all approach to streamline a process, several caveats can be left which prevent legislation from meshing with the justice system. This year, in Levine v. Wyeth, the Supreme Court will address the issue of preemption of claims against name-brand manufacturers' in what could be a landmark victory for consumers. The judgement may very well impact consumer confidence in public agencies such as the FDA and further tarnish the image of drug manufacturers.

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