Generics rise sparks delivery tech need; Interphex speaker

Generics rise sparks delivery tech need; Interphex speaker

The need for novel delivery technologies is greater than ever as firms scramble to extract maximum value from drugs, an Interphex speaker said.

Patent expirations on blockbuster products and a lack of candidates coming through the pipeline to replace lost revenues are pressuring biopharma companies to make more of existing assets. Novel drug delivery technologies can help by extending the life-cycle of a drug facing generic competition.

The need for new drug delivery technologies is greater than ever”Shams Rustom, senior director, product development and manufacturing, at Labopharm said in a presentation at Interphex 2012.

In their efforts to extract maximum value from each drug in their portfolio biopharma companies are looking to drug delivery technologies that improve the asset, for example by increasing convenience.

Similarly, manufacturers of generics are looking to gain an edge over innovator products through the use of novel drug delivery devices. The generics sector has become crowded, Rustom said, and a novel drug delivery device or other improvement can differentiate a product from the competition.

Without a drug delivery technology edge generics manufacturers are left competing on marketing or pricing, areas in which big companies can often use their scale to outmuscle smaller players. By using a novel delivery device generics manufacturers can gain a “huge” advantage, Rustom said.

The drug delivery battlefield could also extend to biosimilars if the US Food and Drug Administration (FDA) resists calls to overturn device flexibility in its current draft guidance. Since publication of the draft guidance innovator biopharma companies have criticised the FDA’s flexibility on device choice.

Stopping dose dumping

An area manufacturers of small molecule generics can improve existing products is release profiles. Some controlled release products suffer from deliberate or unintentional dose dumping – when the active is delivered all at once – and new technologies and formulations can cut this risk.

Dose dumping can happen when a controlled released product interacts with alcohol and, Rustom said, is a “really major issue for the FDA”. Labopharm is developing technologies that prevent dose dumping and is seeking a partner to move its oxycodone product into Phase III, Rustom said.

Related News

West eyes growth from FDA biosimilar delivery flexibility

West eyes growth from FDA biosimilar delivery flexibility

EMA adds formulation, closure flexibility to biosimilar guidance

EMA adds formulation, closure flexibility to biosimilar guidance

Drug delivery news round up featuring Amylin, Zogenix, and more

Round up of drug delivery news

Bayer files patent for chewable dosage manufacturing process

Bayer files patent for chewable dosage manufacturing process

Drug delivery developers must simulate device drops; EMA

Drug delivery developers must simulate device drops; EMA

Sustained release hydrogel: effective for 6 months

New sustained release hydrogel could mean twice-yearly injections for diabetes sufferers

Marshmallow toasting opportunities en route to Interphex in 2010

Lack of Lava-Proof Planes Wont Stop Us Going to Interphex

Drug Industry gathers for Interphex 2013 - Check for live updates

Drug Industry gathers for Interphex 2013 - Check for live updates

PhRMA speaks out against FDA biosimilar flexibility

PhRMA speaks out against FDA biosimilar flexibility

Amgen warns biosimilar draft a threat to production innovation

Amgen warns biosimilar draft a threat to production innovation

Novo Nordisk warns FDA of biosimilar delivery safety fears

Novo Nordisk warns FDA of biosimilar delivery safety fears

Teva eyes delivery devices to gain edge in biosimilar sector

Teva eyes delivery devices to gain edge in biosimilar sector

The BD Physioject

Create painless devices for quicker regulatory approval, says BD

Pfizer and Mylan settle drug delivery patent case with Sanofi

Round-up of the new drug delivery devices on show at Pharmapack 2012

Round-up of the new drug delivery devices on show at Pharmapack 2012

FDA biosimilar guidance permits alternative drug delivery devices

FDA biosimilar guidance permits alternative drug delivery devices

Related Products

See more related products