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Biosimilars Development & its Future

Posted on July 10th, 2017 by in Pharma R&D

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The pharmaceutical industry had really been quite optimistic as of late regarding regulatory overhaul and getting rid of the ever-present ‘red tape’ within the regulatory body in the US, and the FDA had shown a very positive response towards getting biosimilars approved. However, during the last month, biosimilars have come upon some hard times. Regulators rejected two big biosimilars for Amgen’s drugs last month, Pfizer’s Epogen (epoetin alfa) biosimilar and Coherus’s Neulasta (pegfilgrastim) biosimilar.

The reason cited for the Epogen biosimilar rejection was attributed to some of the manufacturing issues with Pfizer’s fill-finish line that had led to a rejection for the second time. This added further momentum to current manufacturing issues in the industry and strengthens the need for higher emphasis on cGMP/ manufacturing quality standards. Reasons cited for the rejection of the pegfilgrastim biosimilar raises more concerns. Besides more manufacturing information, Coherus had also been asked for further reanalyzing of some patient data. This is worrisome, considering there has been no FDA or European EMA approval for this first generation biosimilar to date, and not for lack of effort from the pharma sector.

The only approved biosimilars are in India, one each from Dr. Reddy’s, Intas, Gennova and Lupin. However, they were approved under the old guidelines, which had lower regulatory barriers. Sandoz’s pegfilgrastim biosimilar was rejected by the FDA and withdrawn from EMA for “biosimilarity” concerns. Gedeon Richter faced similar roadblocks in Europe and withdrew its application, while the non-pegylated version had been approved in EMA. Though we are making progress beyond the second generation biosimilars, these regulatory challenges point to the fact that biosimilar research, development, and its characterization appears to have a really high level of complexity.

Many smaller boutique biotech companies which are involved in getting biosimilars approved are facing many challenges. The promise that they originally had thought is no longer seen as a ‘low-hanging fruit’ that anyone could pluck. It’s now viewed only as a mirage, as they have seen the path is much more difficult than what was originally thought. Also, as there are much more biosimilar development players on the horizon, it has become difficult to stand in the fierce completion that now exists to get ‘picked’ by big pharma during its late R&D development stage.

I see that the picture has rather turned gloomier than before due to the FDA’s reluctance for stricter controls on cGMPs, and with even more scrutiny in the clinics and in data analysis. The cost of such a product development has also gone up substantially; the ROI with the R&D investments and the time it would take to reap the value/benefits has substantially gone up.

According to Sue Sutter of Informa, in her recent commentary, she stated that there were at least five products with review timelines coming due in 2017, including some proposed “first-in-class” biosimilars. It’s also possible that some previously rejected applications could be resurrected for review. The FDA can expect to face a barrage of comments on its draft guidance on “interchangeability considerations,” but exactly when it might be tasked with making its first designation remains a question.

As Sue Sutter further stated in her Informa’s Pink Sheet commentary, one certainty ahead for 2017 is the need to renew the Biosimilar User Fee Act (BsUFA) program, the current iteration of which expires September 30. The BsUFA II agreement negotiated in 2016 between the FDA and industry would bring changes in the length of the review clock for 351(k) applications and a bolus of new funding for the agency’s review and policymaking activities. However, the agreement must first pass muster with the new Congress and Trump administration before it takes effect.

The timing for these activities remains to be seen, in terms of the Trump administration’s priorities and taking some positive steps which would ultimately benefit the patients and payers.


For more information on Biosimilars read this whitepaper: Clinical Considerations for Biosimilar Antibodies

All opinions shared in this post are the author’s own.

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