Replies to post #213736 on Biotech Values

[DewDiligence]

Likely the first of many lawsuits by US FoB companies alleging unfair competition by the branded-drug counterparties.

[DewDiligence]

Is the real problem that PCPs are reluctant to switch patients from a long prescribed product.../

That's an impediment to the uptake of FoBs for chronic diseases, but it's not the main impediment, IMO. Rather, the main impediment is the subject of PFE's lawsuit: the branded-drug companies' use of exclusionary contracts with PBMs and third-party payers to try to shut FoBs out of the market.

[DewDiligence]

PFE-JNJ redux—>SHPG sues AGN re dry-eye marketing:

https://www.wsj.com/articles/shire-alleges-allergan-blocked-drug-from-medicare-contracts-1506957534

Shire PLC filed an antitrust suit against Allergan PLC, alleging Allergan’s contracts with Medicare Part D drug plans for its Restasis eye drops effectively blocked access to Shire’s rival drug.

The complaint, filed Monday in federal court in Trenton, N.J., says Shire offered steep discounts in bids to secure insurance coverage of the company’s dry-eye drug Xiidra but the Part D plans refused, due to Allergan’s “bundled discounts, exclusive dealing” and other tactics.

…After an administrator of several Part D plans abandoned a tentative agreement to cover Xiidra and decided against putting the drug on the plans’ formularies, the lawsuit says, Shire asked how it could gain coverage. “You don’t,” Shire’s lawsuit quotes an unnamed plan official replying.

Restasis is AGN's second-largest drug (after Botox), but SHPG's Xiidra has been gaining market share in the category.

Medicare Part D plans are run by private insurance companies under contract to CMS.

[DewDiligence]

PFE—FDA approves Ixifi—(RemicadeFoB)—but product will not be commercialized, according to PFE, because PFE/Celltrion already market the FDA-approved Remicade FoB, Inflectra, which was approved by the FDA in Apr 2016 (#msg-121701314):

https://finance.yahoo.com/news/fda-approves-pfizer-biosimilar-230100940.html

PFE has two Remicade FoBs because it already had one in development when it acquired HSP (#msg-110577169), who also had one in development. The programs were far enough along that PFE decided to keep both of them.

PFE will now presumably seek to out-license the rights to Ixifi.

The US market has a third Remicade FoB: Renflexis from MRK/Samsung, which was approved in Apr 2017 (#msg-130698123).

All told, the FDA has now approved 9 FoBs corresponding to 6 branded products (https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580432.htm ).