I hope you all enjoyed your long weekend. Here’s what’s happening this July 6th in the world of biotech:

BIOSIMILARS OVERVIEW – A new article in Life Science Leader offers a comprehensive background on trends surrounding the biosimilars debate currently in full swing. The article covers biosimilars in unregulated emerging markets, the European biosimilars market, and the follow-on biologics market in the United States. The article recaps the current legislative debate in Congress:

The Pathways for Biosimilar Act (H.R. 1548) introduced by Representatives Anna Eshoo (D-CA), Jay Inslee (D-WA), and Joe Barton (R-TX) requires clinical data, rigorous immunogenicity testing, and limits on interchangeability and substitution provisions for follow-on biologics. Further, it calls for a minimum of 12 years of data exclusivity for innovator companies — a period during which the FDA can’t rely on innovator data to approve follow-on biologics. For example, if a biotechnology drug was approved in 2009, the earliest that FDA could approve an application for a competing follow-on product is 2021. In contrast, The Promoting Innovation and Access to Life-Saving Medicines Act (H.R.1427) introduced by Representatives Henry Waxman (D-CA), Frank Pallone (D-NJ), and Nathan Deal (R-GA) calls for an abbreviated development pathway (at the discretion of the agency), the possibility of substitution or interchangeability (if the follow-on biologics manufacturer can prove a high degree of structural similarity and an identical mode of action), and five years of data exclusivity.

BIO lays out a great argument in favor of the Eshoo-Barton bill, arguing that the 12 year exclusivity agreement strikes a fair balance between lowering health care costs for Americans and recouping the high cost of biotech drug development (which is oftentimes over $1 billion).

INDIAN BIOTECHNOLOGY SECTOR SEEKS GOVERNMENT INCENTIVES – With the new national budget being presented today, Indian biotech firms are hoping for strong government incentives to help spur research and development. The Economic Times reports:

“The government must incentivise R&D (research and development), especially in the biotechnology sector by providing a tax holiday for five years on any new product developed in-house,” Biocon India chairperson Kiran Mazumdar-Shaw told media here.

“The tax holiday should be extended to all biotech products spanning biogenerics, diagnostics, industrial and biotech seeds. With the right political will, this budget can be a turning point towards a stronger, healthier and a more competitive India,” she noted.

The Indian firms point to high levels of English-speaking talent in the industry as an advantage over Chinese, Taiwanese or Korean firms, in securing western partnerships.

FARMERS PLANT MORE BIOTECH CORN – Michiganfarmer.com reports that the use of biotech varieties of corn increased in Michigan and across the nation from last year. These numbers demonstrate widespread agreement that biotech corn offers farmers a wide array of benefits over traditional corn varieties.

Biotechnology varieties accounted for 75% of the corn acres planted in Michigan, up from 72% last year. [...] Nationally, biotechnology varieties of corn totaled 85% of the acres planted, up 5% from 2008.

HELPING PATIENTS GET BACK ON ALL FOUR FEET – Surprisingly, veterinary medicine is one of the few industries to avoid being hit by the economic recession, according to an article in the New York Times.

Various factors keep these types of jobs strong. In veterinary offices, medical advancements and increased use of pet health insurance mean an increase in animal procedures, said Henry Kasper, a supervisory economist at the bureau. “If there’s a way to help a pet, owners are going to ask for it,” he said.

But while the majority of the jobs are in veterinary offices, a growing number of people work in labs at pharmaceutical and biotechnology companies. And because of stringent government regulation of drug and treatment testing, those jobs won’t go away when the economy is bad. What’s more, many of the advances made in veterinary medicine are likely to translate into improved medical practices for humans down the road.