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Replies to post #631052 on NorthWest Biotherapeutics Inc (NWBO)
09/15/23 7:08 AM
09/15/23 8:11 AM
09/15/23 10:29 AM
In the U.S., biologic drugs can obtain a lengthier period of exclusivity, primarily due to the Biologics Price Competition and Innovation Act (BPCIA) which was enacted as part of the Affordable Care Act in 2010.
09/15/23 1:49 PM
09/15/23 7:27 PM
09/15/23 11:57 PM
”Here are some of the basics:
Biologics Exclusivity:
1. 12-Year Exclusivity for Biologics:
- Under the BPCIA, a new biological product that has been licensed (i.e., approved) by the FDA is granted 12 years of exclusivity from the date of first licensure.
- During this 12-year period, the FDA cannot approve a biosimilar or interchangeable biologic that references the original biologic.
- This 12-year exclusivity is separate from patent protection. A biologic could potentially be protected from competition by both its patents and by the 12-year exclusivity.
2. 4-Year Data Exclusivity:
- In addition to the 12-year exclusivity, the original biologic also receives a 4-year data exclusivity from the date of first licensure.
- During this 4-year period, the FDA cannot accept applications for biosimilars or interchangeable biologics that reference the original biologic.
- This means, in practice, that a company wishing to develop a biosimilar or interchangeable version of a new biologic can't even submit their application until 4 years after the original biologic has been licensed.
The rationale behind these exclusivity periods is the complexity and cost of developing biologic drugs. Biologics are typically more complex and costly to develop than traditional small molecule drugs. They are made from living organisms, and their development, manufacturing, and validation processes are intricate.
And both the European Union (EU) and the United Kingdom (UK) also have provisions for biologics exclusivity, though they differ somewhat from the U.S. system. Here's a breakdown:
European Union (EU):
1. Data Exclusivity:
- A new biologic drug (or any other medicinal product) approved in the EU benefits from an **8-year** data exclusivity period. During this time, generic or biosimilar manufacturers cannot rely on the data of the originator's product for their marketing authorization application (MAA).
2. Market Exclusivity:
- After the data exclusivity period, there's a **2-year** market exclusivity period, during which a biosimilar can be approved (using the originator's data), but cannot be marketed.
3. Additional One-Year Protection:
- An additional year of market protection (making it a total of 11 years from the initial authorization) can be granted if, during the first eight years of those 10 years, the marketing authorization holder obtains approval for one or more new therapeutic indications that are judged to bring significant clinical benefit in comparison with existing therapies.
United Kingdom (UK):
- Post-Brexit, the UK largely mirrors the EU's provisions for biologics.
- However, given that the UK might adapt its regulations further after leaving the EU, there could be changes in biologics exclusivity. At this time I know of no such changes.
In both the EU and the UK, these regulatory exclusivity periods are separate from patent protection. This means a biologic can be protected by its patents and also benefit from the regulatory exclusivity, leading to multiple layers of protection against competition.
So the protections are vast, multi-layered and continue to evolve as more process and manufacturing patents for Flaskworks are likely to be filed continuously over coming years by NWBO and/or its successors as they continuously improve their manufacturing and automation processes.
Further, trade secrecy and other substantial protections can last indefinitely, as we see with the bottled sugar water known as Coca Cola. It’s one of many IP protection reasons to control the manufacturing evolution in your own plant and to tightly control which third-party companies touch the process.”
