Entry and competition in generic biologics

Patents for several blockbuster biological products are expected to expire soon. The Food and Drug Administration is examining whether biologies can and should be treated like pharmaceuticals with regard to generics. In contrast with pharmaceuticals, which are manufactured through chemical synthesis, biologies are manufactured through fermentation, a process that is more variable and costly. Regulators might require extensive clinical testing of generic biologies to demonstrate equivalence to the branded product. The focus of the debate on generic biologies has been on legal and health concerns, but there are important economic implications. We combine a theoretical model of generic biologies with regression estimates from generic pharmaceuticals to estimate market entry and prices in the generic biologic market. We find that generic biologies will have high fixed costs from clinical testing and from manufacturing, so there will be less entry than would be expected for generic pharmaceuticals. With fewer generic competitors, generic biologies will be relatively close in price to branded biologies. Policy makers should be prudent in estimating financial benefits of generic biologies for consumers and payers. We also examine possible government strategies to promote generic competition. Copyright © 2007 John Wiley & Sons, Ltd.

Inferring the Effects of Vertical Integration from Entry Games : An Analysis of the Generic Pharmaceutical Industry

This paper introduces a novel method for examining the effects of vertical integration. The basic idea is to estimate the parameters of a vertical entry game. By carefully specifying firms' payoff equations and constructing appropriate tests, it is possible to use estimates on rival profit effects to make inferences about the existence of vertical foreclosure. I estimate the vertical entry model using data from the US generic pharmaceutical industry. The estimates indicate that vertical integration is unlikely to generate anticompetitive foreclosure effects. On the other hand, significant efficiency effects are found to arise from vertical integration. I use the parameter estimates to simulate a policy that bans vertically integrated entry. The simulation results suggest that such a ban is counterproductive; it is likely to reduce entry into smaller markets.

Interferon-free therapy for hepatitis C, how prepared is Australia for biosimilars?

The Hepatitis C virus (HCV) affects some 150 million people worldwide. However, unlike hepatitis A and B there is no vaccination for HCV and approximately 75% of people exposed to HCV develop chronic hepatitis. In Australia, around 226,700 people live with chronic HCV infection costing the government approximately $252 million per year. Historically, the standard approved/licenced treatment for HCV is pegylated interferon with ribavirin. There are major drawbacks with interferon-based therapy including side effects, long duration of therapy, limited access and affordability. Our previous survey of an at-risk population reported HCV treatment coverage of only 5%. Since April 2013, a new class of interferon-free treatments for chronic HCV is subsidised under the Pharmaceutical Benefits Scheme: boceprevir and telaprevir - estimated to cost the Australian Government in excess of $220 million over five years. Other biologic interferon-free therapeutic agents are scheduled to enter the Australian market. Use of small molecule generic pharmaceuticals has been advocated as a means of public cost savings. However, with the new biologic agents, generics (biosimilars) may not be feasible or straightforward, due to long patent life; marketing exclusivity; and regulatory complexity for these newer products.

Tendering for low cost generics in Australia

An Australian federal government committee recently proposed, as a cost-saving measure, the introduction of sealed-bid competitive tendering to exclusively supply the Pharmaceutical Benefits Scheme with specific generic medicines. A similar plan involved an open tender to supply generic products below a government set price, also linked with a reduced patient co-payment as an incentive. These proposals represented an opportunity to encourage the price of generic pharmaceuticals to move closer to the marginal cost of production—a process that could be subsequently applied to innovative (or brand-name) patented medicines in a therapeutic class with many competitors. This article examines these tendering proposals, particularly in relation to the potential for increased involvement of generic pharmaceutical manufacturers in the Australian market.

Generic-branded drug competition and the price for pharmaceuticals in procurement auctions

This paper studies the effects of generic drug’s entry on bidding behavior of drug suppliers in procurement auctions for pharmaceuticals, and the consequences on procurer’s price paid for drugs. Using an unique data set on procurement auctions for off-patent drugs organized by Brazilian public bodies, we surprisingly find no statistically difference between bids and prices paid for generic and branded drugs. On the other hand, some branded drug suppliers leave auctions in which there exists a supplier of generics, whereas the remaining ones lower their bidding price. These findings explain why we find that the presence of any supplier of generic drugs in a procurement auction reduces the price paid for pharmaceuticals by 7 percent. To overcome potential estimation bias due to generic’s entry endogeneity, we exploit variation in the number of days between drug’s patent expiration date and the tendering session. The two-stage estimations document the same pattern as the generalized least square estimations find. This evidence indicates that generic competition affects branded supplier’s behavior in public procurement auctions differently from other markets.

The state of the art defence : defining the Australian experience in the context of pharmaceuticals

One of the defences within Part 3-5 of the Australian Consumer Law is the state of the art, or development risk defence. This defence, although significant, has often been neglected in Australian jurisprudential analysis and has triggered at most generic academic analysis. However, with the rise of pharmaceutical and medical device litigation in Australia, it could become a vital weapon for Australian manufacturers against product liability claims. This paper will firstly review the two ways this defence could operate. It will also discuss the three types of defects which the defence could apply to. This paper aims to determine exactly when and how this defence should apply in Australia, in the context of pharmaceutical product liability claims.

Generic skills in design teams : literature review

Recent developments in networked three dimensional (3D) virtual worlds, and the proliferation of high bandwidth communications technology, have the potential to dramatically improve collaboration in the construction industry. This research project focuses on the early stages of a construction project in which the models for the project are developed and revised. The project investigates three aspects of collaboration in virtual environments: 1. The processes that enable effective collaboration using high bandwidth information communication technology (ICT); 2. The models that allow for multiple disciplines to share their views in a synchronous virtual environment; 3. The generic skills used by individuals and teams when engaging with high bandwidth information communication technology. The third aspect of the project, listed above, led by the University of Newcastle, explores the domain of People and the extent to which they contribute to the effectiveness of virtual teams. This report relates, primarily, to this aspect.

Generic skills in design teams

Recent developments in networked three dimensional (3D) virtual worlds and the proliferation of high bandwidth communications technology have the potential to dramatically improve collaboration in the construction industry. This research project focuses on the early stages of a design/construction project in which models for a project are developed and revised. We have investigated three aspects of collaboration in virtual environments: 1. The processes that enable effective collaboration using high bandwidth information communication technology (ICT); 2. The models that allow for multiple disciplines to share their views in a synchronous virtual environment; 3. The generic skills used by individuals and teams when engaging with high bandwidth information communication technology.

Best Practice Guide : Generic Overview

The construction industry is a key national economic component. It tends to be at the forefront of cyclic changes in the Australian economy. It has a significant impact, both directly and indirectly, on the efficiency and productivity of other industries. Moreover it affects everyone to a greater or lesser extent; through its products whether they are manifested in the physical infrastructure that supports the operation of the economy or through the built environment that directly impacts on the quality of life experienced by individuals. In financial terms the industry makes one of the largest contributions to the Australian economy, accounting for 4.7 per cent of GDP 1 which was worth over $30B in 20012. The construction industry is comprised of a myriad of small firms, across several important sectors including, o Residential building, o Commercial building, o Building services, o Engineering, o Infrastructure o Facilities Management o Property Development Each sector is typified by firms that have distinctive characteristics such as the number of employees, size and value of contracts, number of jobs, and so forth. It tends to be the case that firms operating in commercial building are larger than those involved in residential construction. The largest contractors are found in engineering and infrastructure, as well as in the commercial building sub-sectors. However all sectors are characterised by their reliance upon sub-contractors to carry out on-site operations. Professionals from the various design consultant groups operate across all of these sectors. This description masks one of the most significant underlying causes of inefficiency in the construction industry, namely its fragmentation. The Construction Industry chapter of the 2004 Australian Year Book3, published by the Australian Bureau of Statistics unmasks the industry’s fragmented structure, typified by the large number of operating businesses within it, the vast majority of which are small companies employing less than 5 people. It identifies over 190,000 firms, of which over 90 percent employ less than 5 people. At the other end of the spectrum, firms employing 20 or more people account for fractionally more than one percent of businesses in the industry.