Fights between powerful combatants form the foundation of many mythological tales. In the epic film Clash of the Titans, Perseus, the mortal son of Zeus, must kill the monstrous Kraken before it can annihilate his beloved Princess Andromedra and the citizenry of Joppa. Perseus heroically decapitates the dreaded Gorgon Medusa to obtain the most powerful weapon of his time: her snake-covered head. A single glance from Medusa’s countenance turns the Kraken to stone, the local residents are saved from a horrible fate, and Perseus and Andromeda live happily ever after.
Perseus vanquishing the Kraken was but a small skirmish compared to an even larger battle that is shaping up in the biotech version of this myth. The titans of biopharma are currently taking sides, and the clash of these powerful combatants is likely to be an expensive one. Healthcare consumers will find their wellbeing threatened by a powerful opponent. One of the strongest and most dreaded weapons of modern society has already been brought to bear: armies of lawyers fortified with thick legal briefs. The eventual outcome of this mêlée is unclear, but at stake are billions of dollars in revenue and profits. How was this conflict started, and who are the warriors in this brewing confrontation?
The fracas began when Abbott launched a broadside attack on the burgeoning field of biosimilars by filing a citizens petition with the FDA to protect their rheumatoid arthritis treatment adalimumab (Humira) from competition by biosimilars. This drug is a humanized monoclonal antibody that works by binding to and neutralizing a protein known as TNF. Annual sales of Humira were nearly $8 billion in 2011, and it is poised to become the largest selling drug in the world following the expiration of Pfizer’s patent on atorvastatin (Lipitor) in 2012. Humira’s success in the marketplace has attracted the attention of numerous competitors, who have been planning on making their own versions of this blockbuster medicine when its patent expires. Abbott has asked the FDA not to “accept for filing, file, approve or discuss with any company, or otherwise taking any action indicating that the agency will consider any application or any investigational new drug application for a biosimilar that cites, as its reference product, BLA 125057 for Humira® (adalimumab) or any other product [emphasis mine] for which the biologics license application (BLA) was submitted to FDA prior to March 23, 2010, the date on which the BPCIA was signed into law”.
For those of you who are not familiar with the term, biosimilars are the generic drugs of the biotech world, copies of patented proteins that comprise many of the world’s best selling drugs. Biosimilars are currently not available in the U.S. (with one minor exception) primarily because there is no defined regulatory pathway for their approval. The FDA spent months soliciting input from industry and consumer groups that is being used to plan out a regulatory pathway; their draft guidance was issued recently. The Biologics Price Competition and Innovation Act of 2009 (BPICA) is legislation that establishes the ground rules for resolution of patent disputes that affect the development of biosimilars. BPICA is part of the Affordable Care Act (“Obamacare”), the legality of which is currently being reviewed by the U.S. Supreme Court. Their decision on the Affordable Care Act may significantly affect the status of Abbott’s petition to the FDA.
On what grounds has Abbott asked the FDA not to approve Humira (and other) biosimilars? Most of us know the Fifth Amendment of the U.S. Bill of Rights from the clause featured in countless legal dramas in which a person shall not “be compelled in any criminal case to be a witness against himself”. The Amendment further goes on to state that someone should not “be deprived of life, liberty, or property, without due process of law; nor shall private property be taken for public use, without just compensation”. It is this taking of private property clause that Abbott is hoping will impede the development of biosimilars. Abbott has argued that private property (in this case, trade secrets) contained within biological license applications (BLAs) will be “taken” if these documents are used as part of the process to approve biosimilar proteins for sale. According to Wikipedia, in United States v. 50 Acres of Land (1984), the Supreme Court wrote that “just compensation” is calculated by determining “the market value of the property at the time of the taking contemporaneously paid in money.” In Abbott’s case, this would be a very large sum indeed, given the sales mentioned above.
The legal issues here are complicated and above my pay grade, so I’m not going to attempt to parse the fine points. While Abbott attorneys are clearly hoping for a legal knockout to protect their Humira franchise, the combined forces of those companies that have committed themselves to making biosimilars will likely oppose Abbott’s interpretation of the Amendment. The BioPharma world can be divided into four realms on the basis of biosimilars:
1) Companies that sell or market biologics, but are not planning on making biosimilars at present. Abbott will apparently be spearheading this group, although it is not clear which companies, if any, will be joining them in their legal strategy.
2) Companies that make (or market) their own biologics, and are planning on introducing biosimilar versions of their competitors’ drugs as well. These include Amgen (with partner Watson), Merck, Biogen Idec (joint venture with Samsung), Pfizer, and Novartis.
3) Companies that only plan to make biosimilars, but not branded biologic medicines. This group would include Teva, Baxter (joint venture with Momenta) and Hospira.
4) Companies that are not currently selling either branded biologics or planning on making biosimilars. This would include a large number of generic drug manufacturers.
At stake here is
