According to a news source, industry has given India’s new guidelines for biosimilar drugs, launched August 15, 2012, a “cautious welcome.” The companies are concerned that a requirement for comparative clinical trials will affect their budget allocations, but also know that “[a]pproval ‘without involved clinical trials’ is possible if manufacturers prove close similarity to [a] reference product, and show consistency in production process.” The guidelines were developed with input from stakeholders, and drafters took European and U.S. guidelines into consideration while drafting. The guidelines apparently require that biosimilar manufacturers prove similarity to a reference biologic already approved in the country and sold for at least four years in a regulated market. Safety, efficacy and quality must be comparable to the innovator drug as shown by analytical and clinical trials. See Nature Nanotechnology, September 2012.