REG - AstraZeneca PLC - Annual Financial Report <Origin Href="QuoteRef">AZN.L</Origin> - Part 6
08/03/2016 12:10
- Part 6: For the preceding part double click ID:nRSH4027Re
(which goes off-patent in the US in May 2016). Patent challenges are also
discussed in the Effects of patent litigation in respect of IP rights
risk on page 218. Generic manufacturers may also take advantage of the
failure of certain countries to properly enforce Regulatory
DataProtection and may launch generics during this protected period. This
is a particular risk in some Emerging Markets where appropriate patent
protection may be difficult to obtain or enforce.
Abbreviated approval processes for biosimilars Impact
While no application for a biosimilar has been made in relation to an The extent to which biosimilars would differ from patented biologics on price is unclear. However, due to their complex nature, it is uncertain whether biosimilars would have the same impact on patented biologics that generic products have had on patented small molecule products. In addition, it is uncertain when any such abbreviated approval processes may be fully realised, particularly for more complex protein molecules such as MAbs. Such processes may materially and adversely affect the future commercial prospects for patented biologics, such as the ones that we produce.
AstraZeneca biologic, various regulatory authorities are implementing or
considering abbreviated approval processes for biosimilars that would
compete with patented biologics.For example, in 2010, the US enacted the
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