Conquering the complexities of biologics to get to biosimilars
Teva Pharmaceutical Industries ($TEVA) and Samsung Electronics separately hit the pause button last fall on development of biosimilars of Roche's ($RHHBY) drug Rituxan. Both indicated they were trying to read the tea leaves for what exactly regulators will require for approval. Given that the U.S. has yet to fully map the pathway, their near-simultaneous decisions have cast a pall over the highly anticipated but infinitely complex biosimilars market.
Ganesh Kaundinya, chief scientific officer at biologics and biosimilars developer Momenta Pharmaceuticals ($MNTA), doesn't mind a little regulatory uncertainty. To him, it offers the industry a chance to use evolving science to shape the regulatory approach. Still, Kaundinya understands the difficulty some companies have plunging ahead when they don't know what lies ahead.
"This is not for the faint of heart," the Momenta co-founder says. "This is for somebody who is really committed to going into it with deep pockets and wants to stay in it for several years before they can know the answer to it."
For those responsible for mapping a manufacturing strategy for biosimilars, these uncertainties add to the pressure of an already complex and challenging endeavor. Large-molecule drugs are derived from cells, and a higher level of precision is required in commercial manufacturing than in producing small-molecule products. The proteins are easily affected by variations in the manufacturing process, making it difficult to get a viable, repeatable entity. That also makes manufacturing more expensive, a factor that may weed out some players.
The complexity of biosimilars means that other aspects of the process must be interwoven into manufacturing decisions. Thomas Vanden Boom, vice president, global biologics research, development and manufacturing operations at Hospira ($HSP), says that to be successful, a company requires expertise across a broad range of disciplines. That includes everything from molecular genetics and cell-line development to bioseparations and microbiology, "to name just a few."
Amgen's ($AMGN) Geoff Eich, executive director for research and development policy, believes the evolving nature of the business necessitates having a close and flexible relationship with the regulators who will provide definition to this new market.
Whether biosimilars manufacturers grow this expertise in-house or acquire it on the open market is one of the many, many decisions they must make. Those in the trenches of biologics and biosimilars say any number of manufacturing models will evolve. Biotech companies like Amgen, which are already making biologics and are targeting biosimilars, have the know-how and the infrastructure to do it themselves. Biogen Idec ($BIIB) has lots of biologics manufacturing expertise but is also partnering with colossus Samsung. The South Korean company intends to bring its famed knowledge of cost reduction to bear on biosimilars production in order to sell them at half the price of the innovator product.
Matthew Hudes, U.S. managing principal in biotechnology at Deloitte Consulting, thinks the competitive price pressures that will drive the biosimilars business may very well lead to the first innovations in biologics manufacturing in 15 to 20 years.
"This is potentially a disruptive force in the industry, and it presents an opportunity for process innovation," Hudes says. "We have always thought of the biotech industry as one which had tons of innovation in the area of medicine and manufacturing and process sciences, but it now goes beyond that to innovation in the hardcore manufacturing processes."