Generic / Large Molecule

Pharma shoots for the moon

Reaching new frontiers will require both strategic and financial planning

By Karen Langhauser, Chief Content Director

biosimilar raceWinning the space race was about much more than landing on the moon. Cold War times were tense: Schoolchildren were practicing air raid drills, neighbors were building nuclear fallout shelters and espionage paranoia was spreading widespread distrust. Racing the Soviets to the moon created a sense of patriotism. The U.S. wasn’t just out to prove they were the strongest in space exploration — they were showcasing the country’s superior technology and defeating communism. 

NASA was established in 1958 with a budget of $89 million and by the time the U.S. won the space race by landing on the moon in 1969, the budget had been increased over 4,500 percent. But the last mission departed the moon in 1972, and we haven’t been back since. Needing to win at all costs, the U.S. put massive amounts of time and money into space program development.

This month’s cover story highlights what many consider the next frontier in affordable drugs — biosimilars. As patent expirations on pricey biologics neared, many drugmakers were racing to develop and get regulatory approval for their biosimilars. Everyone wanted to win the biosimilar space race. 

But soon an even more formidable challenge for U.S. biosimilar manufacturers surfaced: Commercialization. Drugmakers trying to get biosimilars on the U.S. market ran into multiple barriers, including patent thickets and litigation, rebate traps and misinformation. Up against costly hurdles, big names such as Boehringer Ingelheim, Merck KGaA and Merck & Co. began abandoning parts or all of their biosimilar missions.

With the sector still in its infancy, biosimilar drugmakers were understandably so preoccupied with development and regulatory issues, that some — like NASA in its nascent stages — failed to build a sustainable strategy for future launches.

Our cover story highlights why drugmakers need to consider all variables, and develop commercialization strategies for biosimilars. Those who apply the same rigor that they applied to development and regulatory to commercialization, taking the time to understand what incentives exist for each stakeholder and choosing their channels wisely, stand a better chance of success.

As for the moon, the Trump administration’s proposed budget has prioritized a lunar landing, and NASA says it’s on target to send humans to the moon by 2028. Scientists have had decades to further analyze and understand this new frontier — taking every factor into consideration, thus increasing the odds of success.

The motivation to go to market and the moon must be driven by the need to explore and improve, not just to win. Not only do biosimilars offer a solution to high drug costs, competition from biosimilars could drive innovators to invest in new opportunities that can deliver additional health advantages.

In the words of astronaut Gene Cernan, the last American to walk on the moon, “America’s challenge of today has forged man’s destiny of tomorrow.”