- Manufacturing-related issues have caused the Food and Drug Administration to reject a biosimilar from Biocon Ltd. and Mylan N.V.
- Before the agency can approve the copycat version of Amgen Inc.'s Neulasta, it needs more chemistry, manufacturing and controls data concerning a recently modified Biocon production facility, the Indian drugmaker said.
- Fortunately for the partners, the agency's complete response letter (CRL) "did not raise any questions on biosimilarity, pharmacokinetic/pharmacodynamic data, clinical data or immunogenicity," according to a Tuesday statement from Biocon. The Indian pharma doesn't expect this latest setback to negatively affect the timing of when it launches the drug commercially in the U.S.
Biocon and Mylan have several biosimilars of big-name drugs waiting in the wings, including Neulasta (pegfilgrastim), Roche AG's Herceptin (trastuzumab) and Roche AG's Avastin (bevacizumab), but manufacturing problems have stonewalled them from market.
Most notably, French regulators found 35 good manufacturing practice (GMP) deficiencies at a Biocon drug substance and product plant in Bangalore, India, during a March 2017 inspection. Of those deficiencies, 11 were considered major and ran the gambit from environmental monitoring concerns to cross contamination risks to inadequate records on batch manufacturing.
Biocon spun the news as a positive, though, highlighting how the French inspectors had given thumbs ups to two of its other Banglapore-based production sites and that it was working on a corrective and preventive actions plan that would bring its non-compliant facility back into line.
French regulators, however, required a re-inspection of the facilities once the improvements were in place, which forced Biocon and Mylan to withdraw their Marketing Authorization Applications for their Herceptin and Neulasta copycats.
The setbacks also bled over to stateside affairs. Last month, the FDA pushed back its target action date for the companies' version of Herceptin three months to December.
And now, another biosimilar faces a longer road to market because of non-compliant manufacturing. That also means more time until Biocon and Mylan can reap returns from these drugs — which could be sizeable. Neulasta, for example, brought in $1.09 billion in revenue during the second quarter alone.
On a broader scale, Biocon's situation adds another tally to the laundry list of Indian drugmakers that have had issues staying compliant. In fact, Indian (and to a wider extent, Asian) pharmaceutical manufacturers have made up the bulk of warning letters issued by the FDA this year.