There has been a lot of talk this year on the highly anticipated entry of biosimilars. With continued rising specialty and oncology drug costs, payers may utilize management strategies that advantage products within a given class with the soonest expected biosimilar option.

With a number of high cost brand drugs nearing their patent expiration dates, HIRC queried commercial health plan pharmacy and medical directors regarding their perspectives on the imminent entry of specialty generics and biosimilars (results below). But first, here is a simple map of the current generics and biosimilars landscape:

Regulatory Summary:

• The Biologics Price Competition and Innovation Act (BPCIA) was signed into law in March 2010 as part of the ACA. The BPCIA establishes an “abbreviated licensure pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed reference product,” also known as the 351(k) pathway.
• Prior to the 351(k) pathway, companies wishing to introduce a biosimilar product had to complete a “full” Biological License Application, otherwise known as the 351(a) pathway. The 351(k) pathway is an abbreviated version of the 351(a) BLA application process.
• The FDA has issued additional draft guidance for the BPCIA since 2010, with some critical unresolved issues such as interchangeability and labeling still pending.

Select Upcoming Patent Expirations:

• 2014 - Copaxone, Neupogen, Leukine
• 2015 - Gleevec, Tracleer, Neulasta, Epogen, Procrit, Rituxan
• 2016 - Humira
• 2017 - Tysabri
• 2018 - Letairis, Remicade, Xolair, Erbitux
• 2019 - Avastin, Herceptin, Orencia, Actemra

Biosimilar Approvals and Applications:

• Teva Pharmaceutical Industries’ biosimilar tbo-filgrastim (Granix) has been available in the US since late 2013, but the company filed a BLA application before the 351(k) pathway became available. Although Teva’s biosimilar references Amgen’s Neuopogen, a key difference is Granix only has one indication whereas Neuopogen has five.
• The FDA only recently accepted its first biosimilar application through the abbreviated 351(k) pathway. Sandoz announced that its biosimilar, filgrastim, was accepted by the FDA on July 24th, with the referenced product also being Amgen’s Neupogen. Additionally, it is expected that Sandoz’s application for pegfilgrastim will be filed shortly, a biosimilar for Amgen’s Neulasta for which patents expire in October 2015.
• On August 8th, Celltrion announced that it had completed the filing procedure for its biosimilar infliximab, for which Janssen/J&J’s Remicade is the reference product.
• Hospira is expected to file in late 2014 for epoetin alpha, the biosimilar to Janssen/J&J’s Procrit and Amgen’s Epogen.

Payer Perspectives:

These developments could certainly shake up the market access landscape for impacted therapy classes. To see how things might play out, HIRC interviewed 20 pharmacy and medical directors from leading health plans in the spring of 2014 regarding their perspectives on generic Copaxone and Teva’s Granix.

Generic Copaxone:

Generic Copaxone (Copaxone is considered a generic rather than a biosimilar) is anticipated, but the timing is uncertain. Teva’s patent on Copaxone expired on May 24th and Momenta, Sandoz, and Mylan have completed ANDA filings for their versions of the generic.

Payers were asked what they expected their plan’s strategy to be in the MS class when generic Copaxone becomes available. Nearly half (47%) of respondents indicated that they expected the generic to be advantaged over the brand in terms of its formulary placement. About 32% of the panel was undecided and 21% stated that their strategy would depend on the price of the generic alternative, in that the price will need to provide an advantage over existing contracts for branded Copaxone.

Teva has since launched a longer-acting, three times weekly formulation and has been rather successful in switching patients to the new version. Once patients are on the three times weekly medication, it is speculated that they will be reluctant to switch to the once daily generic.

Teva’s Granix:

Granix had been available for about four months at the time of HIRC’s payer interviews. Panelists were asked how their plans were reacting to the entry of biosimilars in the white blood cell stimulant class and whether biosimilars would be favored in formulary policies.

Responses fell into five categories:

• No action yet (“Wait and See”) - 30%
• Biosimilars likely to be advantaged in formulary - 25%
• Biosimilar savings appears to be limited - 20%
• Awaiting Neulasta biosimilar and then will pursue contracting strategy - 15%
• Engaging physicians to help with recommendations - 10%

Again, pricing issues loomed high. While the discount on biosimilars alone may not sway payers to advantage the biosimilar over the brand, increased competition could create opportunities for contracting. Those in a “wait and see” mode may hold steady until evidence supporting the safety and efficacy of biosimilar products is built and physician comfort levels rise.

Only time will tell and bring these and the many other predictions and speculations to fruition!

Sources:
HIRC Interviews
FDA Reports and Presentations
Specialty Pharmacy News (Vol. 11, No. 8), August 2014
Teva Doomsday Scenario Seen Averted as Patients Switch, Bloomberg, May 22, 2014
Company Press Releases
Express Scripts Presentation: “Specialty Pharmaceuticals in Development”