The rise of biosimilars
Will it be a game-changer for the life sciences industry, or mark a return to the generics wars of the 1990s? (1000 words, 5 minutes)
Over the last 17 years, biosimilars have emerged as a significant force that has challenged traditional norms in the pharma industry. Biosimilars—biologic products similar to reference biologics in terms of quality, safety, and efficacy—have been steadily gaining market traction since the approval of the first biosimilar in 2006. For industry professionals, this rise presents both opportunities and challenges that demand attention and strategic thinking.
The American Journal of Managed Care notes that one of the driving forces behind the rise of biosimilars is their potential to lower the burden of healthcare costs. As patents for many biologics expire, biosimilars offer a cheaper alternative, making these treatments more accessible worldwide. This shift in the biosimilars industry has been facilitated by regulatory bodies such as the U.S. FDA and the European Medicines Agency, which have provided clear guidelines and a streamlined approval process for biosimilar development.
The global biosimilars market is expanding rapidly, offering pharma companies a chance to diversify their portfolios. According to research published in the journal Pharmacy Practice, companies that enter the biosimilar arena can capitalize on the growing demand for affordable biologic treatments while mitigating the risks associated with research and development.
However, this new era of biosimilars also presents challenges. The website Drug Patent Watch writes that biosimilars often require an increased timeline for production and approval. They also note that the complex nature of biological molecules needs specific nomenclature guidelines and naming biosimilars can be complicated. Also, the intricacies of biosimilar development, including analytical and clinical comparisons, demand specialized expertise which poses some recruitment challenges for pharmaceutical companies. Additionally, the competitive nature of the biosimilar market requires effective strategies for market penetration and differentiation.
Staying informed, collaborating strategically, and embracing innovation are critical steps for survival in the biosimilars market, experts agree.
Additional sources:
THIS WEEK 09/12/23
Roundworks Technologies Private Limited announced the company’s spirometer (alveoair) has received U.S. FDA clearance for distribution in that country. The company specializes in digital therapeutics for respiratory care.
NovaBay Pharmaceuticals and BioStem Technologies entered an agreement under which NovaBay can commercialize BioStem Technologies’ Amniotic Tissue Allograft (Avenova), to be used as a protective covering during the repair of ocular surfaces.
Sinovac Biotech announced the company completed the phase I clinical trial for its broad-spectrum neutralizing antibody product, the Anti-Covid-19 Antibody SA55 Injection and has entered a phase II clinical trial after successfully enrolling its first participant recently.
Celltrion Healthcare launched a campaign to celebrate a decade of biosimilar innovation and research in Europe. The campaign coincides with the 10th anniversary of the European Medicines Agency granting regulatory approval to Remsima, the world's first monoclonal antibody biosimilar of infliximab..
LISTEN UP
In season 10 of the NPC Podcast, Shanil Ebrahim, Partner and National Life Sciences and Healthcare Consulting Leader at Deloitte Canada discusses improving healthcare literacy, expanding the use and integration of healthcare data, and public-private collaborations promoting equity in healthcare. Hear him in conversation with podcast hosts Mitch Shannon, Jim Shea and Mark McElwain.
HEALTHBIZ REWIND
This feature of NPC Healthbiz Weekly looks back at some of the most insightful moments from previous NPC Podcast episodes. In Healthbiz Rewind, you’ll read bold life sci predictions made during the renowned “Prognostication Korner” segment of the NPC Podcast.
Shanil Ebrahim
Partner and National Life Sciences & Healthcare Consulting Leader
Deloitte Canada
Toronto
Season 10, episode 08
Listen to this episode here
What bold predictions will you make about the life sciences industry during the coming 12 to 24 months?
I strongly believe we are going to be the hub of technology-based innovation globally. We have some of the strongest talent in AI, digital health and research. These ecosystems are proliferating across hubs in Toronto, Edmonton, and Montreal, to name a few. I feel these will result in some major breakthroughs in healthcare. Whether it’s diagnostics, therapeutics or the like, it’s going to put us at the forefront globally.
Second, and I don’t know if this is a bold prediction or a bold hope, I want Canada to become a global leader in biomanufacturing and vaccines. We felt how behind we were during the pandemic, and kudos to Canada for responding with several billions of dollars of investment. Although this may sound crazy as a bold prediction or hope to some, many may not know that we were once a leader in vaccine discovery and development, including the discovery of insulin. We were also one of the first leaders in the polio vaccine as well. So, I strongly believe we have all the potential to be a leader once again, and that is going to be my ultimate bold prediction.
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