Reports

Not only generics makers are well placed to move into biosimilars

The lucrative biologicals market already boasts five of the world’s top 10 bestselling medicines [1], and by 2015, IMS Health expects spending on biosimilars to exceed US$2 billion annually, or about 1% of total global spending on biologicals [2]. Although major generics players are well placed to tap into this lucrative market, it is not an exclusive club, and R & D companies also have opportunities [3].

Problematic patent settlements in EU on the decrease

The European Commission’s (EC) second monitoring exercise of patent settlements in the pharmaceutical sector has shown a continuing decline of potentially problematic settlements under EU antitrust rules.

The role of generic drugs in the EU

Today, generic medicines play an essential role in treating disease by increasing the accessibility and affordability of modern day pharmaceuticals.

Diversification of Big Pharma into generics and biosimilars

The infamous patent cliff is upon us and most top multinational companies are highly exposed with thin pipelines [1]. In this current climate, companies can choose to play or defend to optimise their position against generics.

Registration procedures for generic drugs in the EU

In the EU there are several different routes to marketing authorisation for generic drugs.

Centralised Procedure

Marketing authorisation is issued by the EMA and is valid for the entire EU/European Economic Area.

This procedure is optional for generics:

• if the reference product is authorised via a centralised procedure (CP)
• if a CP is in the interests of patients at a EU level.

Quality control for generic drugs

GMP

Generic medicines manufacturers must comply with the strict rules of good manufacturing practice (GMP). This ensures that all medicines—generic and originator alike—are produced consistently and controlled to stringent standards of quality in accordance with current legislation.

Generic drugs – registration, quality, value and sustainability

In the current climate of economic downturn and with the impending ‘patent cliff’ threatening many major pharmaceutical companies, generic medicines are increasingly looking like a good option.

Generic applications in the EU, patents and exclusivity

Types of protection on the originator molecule that have to be taken into account by generic drug manufacturers when filing applications for generic drugs in the EU include the following:

• patents at the time of marketing
• supplementary protection certificates at the time of marketing
• data/regulatory exclusivity at the time of regulatory submission
• market exclusivity at the time of marketing.

Big Pharma and the generics industry

What with growth in the global pharmaceutical market slowing and even stabilising and the impending ‘patent cliff’ looming, Big Pharma needs to look for other options.

Impact of healthcare reforms

Even though global pharmaceutical market growth has stabilised, it still means a rising medicines bill. The global pharmaceutical market is expected to add nearly US$300 billion through 2014, topping US$1.1 trillion [1].