The Q&A – At long last…the FDA approves generic Copaxone – the key questions

A prolonged pursuit by developers to launch generic versions of Teva's multi-billion dollar multiple sclerosis treatment Copaxone in the US market appears to be nearing its conclusion, with Novartis and Momenta granted FDA approval for Glatopa last week.

With patent exclusivity for Copaxone extended until September, Glatopa may not launch for some months; nevertheless, the approval is a key one…

Will physicians adopt generic Copaxone?

As an inherently complex product, much of Teva's defence strategy in looking to delay approval of generics has centred on the difficulties in accurately demonstrating a suitably comparable efficacy and safety profile to the branded version.

Thus, there has been some debate as to whether adoption of any approved, interchangeable generic Copaxone will come close to matching that of traditional generic launches. FirstWord's own research in this area, including a Physician Views poll of 55 US-based neurologists last year, indicates that such concerns may be overplayed.

An executive vice president at one of the leading US pharmacy benefit managers told FirstWord that the FDA's decision to approve Glatopa as being AB-rated will significantly improve the likelihood of physicians adopting the product from a clinical perspective. That said, a leading US-based multiple sclerosis key opinion leader told FirstWord that questions over a generic version will remain, given that Copaxone triggers a somewhat misunderstood immune-response in patients.

Will patients be happy to switch back?

If neurologists are happy to prescribe generic Copaxone, this will sharpen focus on the effectiveness of Teva's 'switch' strategy and raises the question as to whether patients now receiving a new 40mg dosage of Copaxone (dosed 3 times a week rather than once daily) would be compliant in switching back to a generic 20mg version dosed once a day? The success of Teva's strategy (67 percent of Copaxone volume is now accounted for by the 40mg version) has exceeded expectations.

Uptake of 40mg Copaxone has been boosted in part by a discount versus the original 20mg version – which has facilitated support among payers – however, adoption has also been driven by a strong message in improved convenience, the anonymous PBM executive vice president told FirstWord. As a "single source" generic with associated level of discounting, Glatopa can be expected to gain the majority of its share among new patient starts.

The KOL provides a similar view, suggesting that a potent combination of reduced price and improved convenience has driven rapid adoption of Copaxone 40mg. Payers will seek to drive a reverse switch, he suggests, but are likely to face difficulty in achieving this, particularly with patient support programmes already well established to retain brand share at the expense of generic uptake.

What about other generic Copaxone launches?

Analysts have provided mixed initial assessment as to whether approval of Glatopa either creates a more defined path for other generic Copaxone applicants or whether the decision to only approve Novartis and Momenta's product raises questions about the short term validity of other applications; Mylan, for example, had confidently predicted that it would be positioned among the first raft of approvals.

Availability of multi-source generic versions of 20mg Copaxone would make an "earth shattering" difference in terms of expected price discounting, the effect on branded manufacturers being required to compete more aggressively on rebating (in order to retain preferred formulary status) and the aggressiveness of payers to promote initial access to generic Copaxone at the expense of the 40mg branded version or branded oral agents, said the PBM executive vice president. Similarly, approval of a AB rated 40mg Copaxone generic – some analysts suggest the timeline for this could have now shortened (given that key patents are formulation focused) – would have profound repercussions on the MS payer space, he added.

At the very least the approval "presents opportunity for the discussion to shift to pricing, which will see some pressure as we assume that payers are very interested in making this happen after several years of large price increases in the space," argue analysts at Bank of America Merrill Lynch. The PBM executive concurs: "branded manufacturers know that we are looking to manage specialty care segments more effectively and MS should be easier to manage that hepatitis C or rheumatoid arthritis, for example. The (Teva) stock price reaction demonstrates that branded players know they have to up their game in terms of rebating."

What about the FDA's role?

The seven-year pursuit of approval for generic Copaxone at least partially illustrates that the FDA has not taken the decision to greenlight Glatopa lightly.

Furthermore, analysts at Bernstein noted "we were struck by how much FDA relied on testing and data analysis done by its own staff in its own scientific labs," in reference to the administration developing its own methodologies for comparing branded and generic samples of Copaxone and analysing gene expression data. This process could make approval decisions "more objective' for subsequent filers, may make it more difficult to change generic approvals in court and "suggests longer approval cycles for difficult-to-make generics, but higher odds of eventual approval," they add.

What impact on Novartis/Teva?

Aside from the impact that generic Copaxone will have on the multiple sclerosis market, approval of this product provides a further reputational boost to Sandoz, Novartis' generics division.

Secured shortly after approval of Sandoz's Zarxio as the first US biosimilar, the FDA's decision to greenlight Glatopa "highlights Sandoz's prowess in complex generics," note analysts at Morgan Stanley. "It further highlights Novartis/Sandoz's strength in complex generics & biosimilars at a time when prospects for these drugs is a key focus for the market," they add.

For Teva, the first (albeit small) crack in the Copaxone franchise is likely to advance the strategic narrative, potentially sharpening focus on the company's M&A aspirations (ViewPoints: Approval of generic Copaxone will sharpen focus on Teva’s M&A efforts).

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