In 2017, there were 46 novel drug approvals in the U.S., according to the FDA. However, the majority (67%) of these drug approvals represent later-to-market entrants that will be vying for share in an increasingly competitive landscape. For example, take Verzenio, Lilly’s CDK-inhibitor for HR-positive breast cancer, which was third to market after Pfizer’s Ibrance and Novartis’s Kisqali. Or Steglatro, the Merck and Pfizer fourth-to-market SGLT-2 drug, which came in after Invokana, Farxiga and Jardiance.


Then there are the biosimilars that are just starting to enter the U.S. market, some of which are approved and marketed while others either are sitting on the sidelines waiting for the dust to settle on the patent disputes, or are in the pipeline and likely will launch in tsunami-like waves to compete with some of the biggest biologics available today. Many biosimilar launches will occur at or around the same time, adding further complexity and redefining what it means to have an early mover advantage. News headlines have gone from talking about a first-to-market, novel mechanism of action product to treat a disease to reporting on a company that’s suing another for anticompetitive practices, which is the case for the ongoing litigation with Pfizer’s Inflectra and Johnson & Johnson’s Remicade. To make matters worse for the Pfizer/J&J battle, Renflexis, the second-to-market biosimilar infliximab from Merck/Samsung, just launched this past year as well, and there are other infliximabs planning to enter the market.


What does all of this competition mean for biopharma companies trying to maximize their assets? Here are five things to think about as you prepare to enter the market or defend your existing turf:

  1. Understand that staying competitive in the marketplace is an ongoing process. Competitive intelligence and a thoughtful assessment of your market’s future state at various points in time will be critical for long-term success. Companies that conduct initial assessments can develop rich insights on the competition’s commercial capabilities, portfolio of assets and previously identified strategies that may predict future behaviors, company risk profiles and expected share of voice in the market. However, it will be helpful to pressure-test assumptions over time by learning from the resources that are on the ground and creating feedback mechanisms to gather field intelligence as things start to unfold.
  2. Identify trigger points that will drive organizational decisions and reactions. When will a manufacturer have to pull the “payer ripcord”? Having a decision-driven framework for evaluating how the market plays out can not only inform your strategy and key go-to-market plan but also drive broader investment decisions. In marketplaces such as biosimilars, evolving clarity on many regulatory, legal and commercial areas only further heighten the importance of the approach.
  3. Consider where you want to win vs. where you have the right to win. Develop strategies to promote your value proposition in the segments of the market where it will resonate most. Take the mind of the competition into account when making decisions, as the competition might also have a similar story to yours and may very well be the incumbent whose position you are looking to usurp. Ensure that investments and resources align to segments and geographies that will influence business success, and avoid boiling the ocean with a one-size-fits-all approach.
  4. Don’t treat differentiation as simply a clinical exercise. Beyond-the-pill solutions can create mutually beneficial outcomes for all parties involved. Offerings may take many forms, from education to evidence generation, reimbursement support or risk-sharing agreements, but they need to focus on the win-win with customers. Design offerings with the customer in mind by understanding her needs and objectives.
  5. Remember that it’s not a race; it’s a journey. The actions taken today have cascading effects on how a market plays out and the long-term viability of a given market. Understanding actions, reactions and future responses will help inform decisions today and in the future. To enable short-term decisions to be nimble but sustainable, it’s critical to thoughtfully play out these different scenarios over time and create capabilities to support long-term impact evaluation.

Increasing competition brings fragmentation to the marketplace, so biopharma companies have to focus their efforts. Within the fight for market share taking place with waves of new launches, companies should take an outward and inward look at the environment and their competition and plan accordingly. Generating insights and investing in execution-oriented activities can help refine the focus and set companies up for success.