The drug is designed to target a mutated form of a gene known as KRAS that occurs in about 13% of non-small cell lung cancers, the most common form of the disease. Earlier in October, Bristol Myers Squibb had agreed to buy Mirati for up to $5.8 billion, to diversify its oncology business with Krazati.
The popular rheumatoid arthritis medication Humira by AbbVie has a biosimilar counterpart that India's Biocon Biologics announced on Monday has been made available in the United States. Hulio will be offered for a list price that is 5% less than Humira's current list price, according to Biocon Biologics, a division of Biocon. The list price of Humira is $6,922 per carton. The biosimilar would also be accessible through a different plan at a list price that is roughly 85% less expensive than Humira.
The group of six states filed an amended complaint Thursday, joining the FTC which last month filed suit opposing the deal because it would give Amgen "monopoly positions" for medicines used to treat thyroid eye disease and chronic refractory gout.
Shanghvi, the son of Sun Pharma's founder-promoter and managing director Dilip Shanghvi, has been heading key functions, including emerging markets, global generic R&D, global generic business development, and active pharmaceutical ingredient since joining the firm in 2006.
Stelara is a biologic drug, meaning it is derived from living cells and cannot be exactly duplicated. A 2009 law allows companies to make biosimilar versions of complex biologic drugs that can be substituted for them, much like cheaper generic versions of conventional drugs, which are exact copies of the branded medicines.
Absent an agreement, Amgen could have sought to close the deal as early as Monday. Under the order, Amgen and Horizon will not close their transaction until the earlier of September 15, or the second business day after the court rules on the FTC's request for a preliminary injunction.
The nine justices unanimously upheld a lower court's ruling that had invalidated Amgen's patents on the grounds that the Thousand Oaks, California-based drugmaker had failed to provide a roadmap for recreating, or "enabling," the full scope of its claimed innovation.
The U.S. Federal Trade Commission's (FTC) lawsuit filed on Tuesday surprised those who had brushed off the antitrust risk in Amgen's deal because of its limited business overlap with Horizon.
Last year, Amgen agreed to buy Horizon to strengthen its rare diseases drugs portfolio and said it hopes to complete the deal in the first half of 2023. Amgen said on Monday it wasn't aware of any decision made by the agency.
The U.S. Court of Appeals for the Federal Circuit affirmed a New Jersey federal court's ruling that Amgen patents covering the drug were valid and that the proposed generics would infringe them.
Amgen is appealing a lower court's ruling that invalidated two of its patents on Repatha, a drug that can reduce risk of heart attack and stroke in people with heart disease, after a legal fight with French drugmaker Sanofi and its partner Regeneron Pharmaceuticals Inc.
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