Biosimilars are touted as the future of innovative biologic medicines, offering more affordable treatment options for patients worldwide. However, with the impending patent expiry of blockbuster drugs like Humira, there are still many unanswered questions about how the biosimilar market will evolve.
What are biosimilars?
Biosimilars are biologic medicines that are developed to be similar to an existing approved biologic drug, known as the reference product. They are engineered to be highly similar to the original biologic in terms of quality characteristics, biological activity, safety and efficacy. However, biosimilars are not generic copies of biologics. Developing a biosimilar is more challenging than a generic small molecule drug due to the complexity of biologics which are produced through living systems. Stringent regulatory requirements need to be fulfilled to demonstrate biosimilarity.
The first Humira biosimilar
Humira (adalimumab) developed by AbbVie is the highest selling drug globally. It generated over $20 billion in annual sales mainly treating autoimmune conditions like rheumatoid arthritis. Its patent expires in 2023 in the US and EU markets. However, the first Humira Biosimilar, Idacio, developed by Samsung Bioepis was approved by the European Medicines Agency (EMA) in August 2017. Other biosimilars are also under review. The approval of Idacio has set an important precedent and demonstrated the regulatory pathway for the approval of additional Humira biosimilars in key markets.
Impact on pricing and patient access
The introduction of Humira biosimilars is anticipated to significantly reduced drug costs and expand access to treatment. Experts estimate biosimilars could lower Humira's list price by 15-30%. This could translate to annual savings of $1-2 billion for the US healthcare system alone. Lower costs would allow more patients to initiate and maintain Humira therapy. For example, in Denmark where three Humira biosimilars are available, the uptake has increased to over 60% of all adalimumab prescriptions due to lower prices. Wider availability of biosimilars is expected to have a similar positive impact globally.
Challenges to achieve price reductions
However, there are concerns that not all the potential savings from biosimilars may be realised. Pharmaceutical companies use a variety of strategies to retain market share such as patient loyalty programs, copay cards and authorised generics sold at only slightly lower prices. Manufacturers of Humira have already launched these programs worth billions indicating they will face biosimilars aggressively. Regulatory issues like interchangeability status and restrictive formulary placement can reduce uptake and competition as well. Ongoing litigation between manufacturers may further delay biosimilar approvals and benefits for years. Overcoming these hurdles will be important for maximising the affordability impact of biosimilars.
Prospects for Humira biosimilars in the US
The US represents over 50% of Humira's global sales currently. But biosimilar approvals have come slowly in the US compared to Europe due to the complexity of the regulatory pathway. The first Humira biosimilar, Amjevita, was only approved in September 2016. Several others are under review but face patent litigation delays. It is anticipated wider availability of Humira biosimilars starting 2023 could lower the drug's US sales by $2-4 billion per year. However, the barriers highlighted previously may dampen uptake and competitive pressure on prices in the short term compared to a quicker uptake seen in some European markets. Over time, as more are approved and market dynamics evolve the full generic-like price reductions may be realised in the US as well.
Manufacturer strategies for the biosimilar era
Facing biosimilar competition, manufacturers are pursuing strategies to transition patients to newer product lines and indications. AbbVie is developing next-generation Humira formulations like adalimumab-adaz to extend market exclusivity. They are also investigating Humira for additional autoimmune and cancer indications. More approved uses would make switching to biosimilars logistically complex. In 2018, Humira's sales grew 16% year-over-year indicating these strategies are maintaining growth. As the adalimumab biosimilar market matures, an increasing proportion of global Humira sales will come from new territories, formulations and expanded label approvals. This ensures AbbVie sustains Humira's revenues despite impending patent expiry and biosimilar erosion.
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