The US Food and Drug Administration (FDA) issued the Biosimilar Action Plan (BAP) earlier this week, as part of a greater movement to encourage and reward innovation in drug development, while stimulating timely, generic competition.
The BAP focuses on improving four key areas in the biosimilar space: biosimilar development and approval, scientific and regulatory clarity, the understanding of biosimilars among patients, clinicians, and payers, and market competition.
“Our aim is to reduce the time, uncertainty and cost of drug development, while also supporting a competitive market through the efficient approval of lower-cost generic, biosimilar and interchangeable alternatives after the expiration of patents or other statutory exclusivities,” commissioner Scott Gottlieb told delegates on Wednesday.
According to Gottlieb, competition in the biosimilar industry is largely “anaemic.”
“It’s anaemic because consolidation across the supply chain has made it more attractive for manufacturers, Pharmacy Benefit Managers, Group Purchasing Organisations and distributors to split monopoly profits through lucrative volume-based rebates on reference biologics—or on bundles of biologics and other products—rather than embrace biosimilar competition and lower prices,” he said.
In September last year, Pfizer accused Johnson & Johnson (J&J) of anticompetitive practices concerning its bestselling monoclonal antibody (mAb) Remicade (infliximab). According to Pfizer, J&J attempted to block coverage of its Remicade biosimilar, Inflectra, via biosimilar-exclusion contracts.
Pfizer also claimed J&J offered discounts on its reference product to providers, dependent on them not purchasing infliximab alternatives.
A Pfizer spokesperson told us the case is still in the early stages, with J&J’s motion to dismiss having been fully briefed since the end of June. “We are waiting for the judge to issue a ruling on the motion, but cannot predict the exact date,” we were told.
Gottlieb continued: “The branded drug industry didn’t build its success by being business naïve. They are smart competitors.
“Preserving that balance between innovation and competition requires modernising regulatory requirements to maintain efficient, predictable and science-based pathways for drug review.”
AbbVie highlighted the importance of this balance just one day earlier, after a licensing deal with Mylan ensured that no competitor would bring a biosimilar version of its blockbuster Humira (adalimumab) to the US market until 2023.
“We understand the importance of balancing innovation and accessibility, and our agreement with Mylan for its Humira biosimilar maintains that balance,” said AbbVie’s executive vice president, external affairs, general counsel and corporate secretary, Laura Schumacher in a statement.
Novartis
According to Gottlieb, the FDA wants drugmakers to continue to offer the benefits of improved versions of originator biologics, which could include biologics that target multiple targets of disease at the same time.
“Biologic manufacturers have a right to defend their legitimate intellectual property interests,” he added.
Sandoz – the generics arm of Novartis – agreed that the sharing of knowledge plays an important role in scientific innovation. Sandoz became the first company to receive FDA approval for a biosimilar product in 2015, with Zarxio (filgrastim-snd), an alternative to Amgen’s Neupogen.
“We also believe that intellectual property is the foundation that enables the investment in innovation and provides risk protection to ensure that new medicines are developed,” a Novartis spokesperson told us.
According to Novartis, the industry has a responsibility to ensure that healthcare systems are sustainable, and that biosimilars and generics help enable sustainability.
“We believe in collaborative measures to ensure a fair approach to competition that enables access, reduces costs, and creates the space for continued innovation. We remain supportive of policies that encourage patient access to these innovations. Access will depend on reforms that require every incumbent in the drug supply chain to place patients first in their decision-making process,” we were told.
Roche, more to lose?
Roche’s subsidiary, Genentech, is the subject of much biosimilar competition in the monoclonal antibody space, primarily in Europe. In December 2017, the FDA approved Mylan and Biocon’s biosimilar version of Roche’s Herceptin (trastuzumab). Teva and Celltrion, Amgen and Allergan, and Pfizer are also looking to market Herceptin alternatives in the US.
Celltrion, Samsung Biologics, and Sandoz have also attempted to bring a biosimilar version of Roche’s Rituxan (rituximab) – co-developed with Biogen – to market.
A Roche spokesperson told us the Swiss firm supports the FDA’s efforts to implement a science-based pathway for the approval of biosimilars, and ‘looks forward’ to engaging in open dialogue with the FDA “to ensure patient choice and access to the treatments they need today as well as a positive environment for scientific innovation that enables the breakthrough medicines of the future.”
“The availability of more treatment options is good for patients and the introduction of biosimilars should also drive healthy competition, bringing savings to healthcare system[s] overall,” she told us.
“As an experienced manufacturer of biologic medicines, we’re pleased to provide perspectives that can help support the successful introduction of biosimilars, while focusing our own efforts on the discovery and development of new medicines for people facing serious diseases,” we were told.
Pfizer: More can be done to tear down barriers
US-headquartered Pfizer is encouraged by the FDA and the current administration’s support for biosimilars, a spokesperson from the firm told us.
Pfizer has received three biosimilar approvals in the US to date: Inflectra (infliximab) in 2016, Ixifi (infliximab-qbtx) in December 2017 – both of which are alternatives to J&J’s Remicade – and in May this year, Pfizer subsidiary Hospira received FDA-approval for an alternative to Amgen’s Epogen, Retacrit (epoetin alfa-epbx).
The spokesperson continued: “The Biosimilars Action Plan is an important step forward for cultivating a robust biosimilars market in the US with the potential to improve the lives of millions of Americans.
“But more work needs to be done to tear down market barriers to biosimilars and it will require cooperation from a robust coalition of stakeholders, from Congress and insurers to the FDA, to biologics manufacturers, and the middle-men.”