However, representatives argued that 14 years should be provided due to the complexity and expense involved in developing biologics.375 Amgen submits that data protection is particularly important in the area of biologics, due to the scientific differences between biotechnology medicines and traditional small molecules, and argues that data protection should be increased.376 Data protection is perceived as a valuable instrument that protects years of financial investment and significant effort in the development of new medicines. Amgen submit that this was particularly so for biologic medicines: Without data exclusivity, innovative biologics will be at risk of imitation long before they have an opportunity to recover the cost of research and development or earn a return on the investment.
This phentermine tramadol will dramatically erode an incentive to risk the substantial sums of money and many years of effort required to develop innovative biologic medicines.377 Grabowski et al demonstrated that where remaining patent life is short at the time of market entry, data protection greatly enhanced investment incentives. Conversely, where the biologic patent was considered to have strong patent protection, this on oxycodone phenergan its own was sufficient to maintain investment incentives.378 Arguments against extending data protection for biologics primarily focus on the lack of need for such an extension, as the inherent complexity of the products makes them difficult to replicate. The US FTC concluded that given the high costs of development, competition from generics would be muted.379 The findings of the FTC also suggest that patent protection for biologics is adequate, even though they may be based on naturally occurring substances that are not patentable subject matter. The FTC also found that biologics are difficult to design around,380, although some in the biologics sector argue that the opposite is true, making patent protection unreliable.381 Data protection provides additional market exclusivity only to the hydrocodone without a prescription or medical records fast shipping extent that a patent can be circumvented by a biosimilar, phentermine tramadol or the remaining period of patent protection after the approval of the originator biologic is shorter than the data protection period.382 As Amgen's submission illustrates, in this situation, data protection is considered an important factor to preserve the incentive to invest in developing biologics by originator companies. Draft finding 9.phentermine tramadol 1: The Panel considered whether data phentermine tramadol protection should be increased for biologics. The Panel is unconvinced that an extension of data protection would be beneficial. The Panel found no evidence to suggest that patents phentermine tramadol for biologics will be more difficult to obtain than patents for small molecule drugs, or that effective patent life would be substantially reduced by the complexity of biologics.
Additionally, given that the generic manufacturer of a biosimilar cannot rely solely on the clinical data of the reference product to obtain regulatory approval, there is reduced advantage to be gained from granting an additional term of data protection. The Panel is of the view that given the substantial market opportunity that will arise in the near future for biosimilars, and the corresponding potential for cost savings to the PBS and consumers, competition in this area should be encouraged. At present the Panel does not have sufficient evidence to support an increase in data protection beyond the current five year period for biologics. Integrated approach to the pharmaceutical system 10.1. Current situation The pharmaceutical system is complex. It involves a number of complicated government-administered schemes and processes: R&D funding and assistance schemes; the patent system; regulatory approval processes; and the PBS listing and pricing process.
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