Cultivating Biosimilars

Pharma's challenge is to mirror both process and product to create "similar" biologic therapies.

By Doug Bartholomew, Contributing Editor

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Single-use, or disposable materials may include bioreactors, solution storage containers, filters and other items that can be used for one or even a few production runs before being replaced with a new set of materials. They are attractive for a variety of reasons — they scale up rapidly and offer flexibility when making a quick switch between products being manufactured.

“Many of the original biologics products “were developed 15 or 20 years ago using what were state-of-the-art processes back then,” Wong points out. “Today there are new technologies and new methods that have increased the productivity of making a biological product, which means you can drive down the cost of producing biosimilars.”

Flexibility in manufacturing also enables companies to react faster to shifts in the market. “We have been investing in fast, flexible and nimble technologies that offer a very good approach to manufacturing biosimilars,” Fung says. “It allows you to react to the market as it changes, so that if you have under-predicted the demand, these facilities are quicker to construct. Similarly, they help you to not over-invest in a particular product. It allows for a margin of error when predicting your capacity and demand.”

The use of more up-to-date technologies in the manufacturing process may mean that biosimilars will be produced through the use of slightly different processes or even different materials to yield a highly similar end result. “An expected difference is that our processes will be different than those used a decade ago,” Fung explains. “This means using more state-of-the-art technologies. Or we might use a different reagent in a process.”

Manufacturers today, by tweaking or refining their processes, may actually come up with an improved product when making a biosimilar. “The media in which you cultivate the cells can have an impact on the product,” Fung adds. “We use this knowledge to optimize the product — in other words, we deliberately use media to optimize the product to affect it in the way we desire.”

Wong believes the market for biosimilars will be largely taken over by drug firms that already are making biologics and have extensive experience with their development and production. That said, he recognizes that the party is wide open to others. Some companies are already experienced in the art of biologicals, some may develop those skills on their own, and others may form a collaboration with a company already skilled in this area, he adds.

“A lot of generic chemical drug manufacturers have already started developing their own programs for biosimilars,” Wong says. “The barrier to enter the U.S. market is high, but if the potential for earnings is there, it’s worth it.”

As might be expected, biosimilars present an additional challenge once the product is ready for packaging. As an example, biosimilars have the potential to react more strongly to the silicon film lining the inside of a glass syringe or to the chemical makeup of a container’s stopper. The result is that biosimilar manufacturers will have to take special care when designing the packaging to ensure product safety, purity and efficacy.

Amgen’s Fung says the company plans to package its biosimilars in a way that is familiar to the end user. “We would look to make the packaging transparent and seamless, so it would look and feel the same to the end user like any biologic,” he says.

Likewise, the supply chain for biosimilars also will come in for greater scrutiny than that for chemical drugs. In Europe, the European Commission requires all EU member countries to take special measures to identify all biological medicines that are prescribed, dispensed and sold. Ultimately, these requirements are imposed on physicians, pharmacies and other healthcare professionals.

As the pharmaceutical industry prepares to launch an initial wave of biosimilar drugs to tap the $80 billion worth of biologics set to go off patent in a few years, there is a heightened sense of both the opportunities and the challenges this new market portends.

Drug manufacturers are acutely aware of the various obstacles they must navigate to be successful biosimilar producers. While regulatory concerns may loom large today, the labyrinth of manufacturing issues posed by biosimilars may prove to be even more challenging down the road.

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