Generics makers build up capabilities, FDA collaboration

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Generics makers build up capabilities, FDA collaboration

By Sandra Levy - 02/19/2019
After a year that saw record-high generic and biosimilar drug approvals by the Food and Drug Administration, many manufacturers said that 2019 should be more of the same. More importantly, many industry officials said they are prepared for this and are eager to take advantage of the government’s new and more open posture.

The agency gave its full or tentative approval to 971 generic drugs during fiscal year 2018, a huge difference from the 409 drugs approved in 2014, according to a recent PricewaterhouseCoopers report.

The spike in the number of generics green-lighted by the FDA comes on the heels of President Trump’s Blueprint to Lower Drug Prices and the FDA’s Reauthorization Act in 2017, which greatly increased FDA’s funding and authority. Additionally, under Trump’s appointed commissioner, Scott Gottlieb, the FDA has launched the Drug Competition Action Plan and the Biosimilars Action Plan, both broadly aimed at lowering prices through increased competition in the markets.

While many generic drug manufacturers applaud the FDA and the Trump administration for creating more opportunities, their actions also have created challenges, leading some manufacturers to enhance or revamp their strategies for success.

These new approaches include making greater investments in research and development, breaking ground on new manufacturing plants and state-of-the-art labs, diversifying their portfolio, and hiring additional staff with greater scientific and regulatory proficiency.

Investing in the Future
Srinivasa Rao, Dr. Reddy’s vice president and head of regulatory affairs North America generics, praised the FDA’s new posture, which he said has spurred Dr. Reddy’s to ramp up its investments, including adding research and development staff in India, where the company is headquartered.

“We constantly increase our technology space with the latest state-of-the-art equipment,” Rao said.

Hefty investments also are being made at Mayne Pharma, according to CEO Scott Richards, who said the South Australian company with U.S. headquarters in Raleigh, N.C., has made significant investments in its staff, facilities, and R&D capabilities, including more than $140 million to expand its manufacturing capabilities and capacity globally.

Mayne Pharma also recently completed a new solid-dose oral manufacturing plant in Greenville, N.C., which Richards said quadrupled its manufacturing capacity and added multi-particulate layering, bead coating fluid bed technology and commercial-scale handling of potent compounds.

“The new facility allows Mayne Pharma to work more effectively with challenging and difficult drug substances,” said Richards, who noted that more than 15 new products are targeted to launch from this site by the end of next year.

Additionally, Mayne Pharma invested $35 million in R&D last year, focused on the creation of first-to-market generics, hard-to-manufacture products, and complex products utilizing drug delivery capabilities the company has in-house or through its strategic alliance partners.

R&D also is a factor in Bridgewater Township, N.J.-based Amneal’s new strategy in light of the FDA’s recent actions. Andy Boyer, Amneal’s executive vice president of commercial operations, said it is focused on portfolio selection, combined with execution from its R&D, legal, regulatory and operations arms. “Everything starts with quality and supply from a customer standpoint,” he said. “Operations, quality and regulatory are the key functional areas that allow Amneal to be successful in delivering products of high quality and high service levels.”

Having a discerning eye for what products are brought to market is a key component of Amici Pharmaceuticals’ efforts. Amanda Samojedny, Amici’s director of operations, said the Melville, N.Y.-based company is selective in the types of drugs for which drugs it pursues approval.

“Given that we are a newer drug manufacturer, our focus has been on pursuing generic drug approvals on items for which there is not enough competition in the market, or none at all,” Samojedny said.

A diversified business model has been an important ongoing strategy for many generic drug makers, but it is increasing in importance in the current climate of speedier approvals, which offers companies the opportunity to diversify quickly. This approach is central to Upsher-Smith Labs’ efforts, according to Jennifer Colvin, vice president of marketing, corporate communications and commercial analytics at the Maple Grove, Minn.-based manufacturer.

“We are focused on significantly increasing our pipeline of products to include new dosage forms, as well as more traditional and specialty products,” Colvin said.

Mayne Pharma’s Richards agreed that innovation is key.

“Our pipeline today includes a much broader array of dosage forms, including transdermal patches, hormonal drug/devices, topical creams, ointments and foams, as well as our history in immediate release and modified release tablets and capsules,” he said.

As companies like Upsher-Smith and Mayne Pharma pursue novel dosage forms, Dr. Reddy’s strategy is focused on developing complex generic products. Doing so “allows us to differentiate ourselves from our competitors,” Rao said.

Regardless of the dosage form or drug complexity, the secret to success for Camber Pharmaceuticals, according to president Kon Ostaficiuk, is a focus beyond generic alternatives to big-ticket drugs. “Camber targets products that will or may have a larger impact on an individual’s wellness and not just ‘blockbusters,’” he said.

Passing Regulatory Muster
While generics companies are quick to point out that they always have worked diligently to gain FDA approval, they appear to be working even harder prior to submission. A shorter approval process — as Gottlieb has stressed — does not mean a less thorough one. Indeed, the expedited process requires manufacturers to provide more clinical data than was previously required.

“It requires more upfront investment to produce a quality ANDA submission and quite a bit of work up front,” said Rao of Dr. Reddy’s. “You need to understand this process well.”

Generics makers are keenly aware that they must continue to enhance their processes and innovate as they seek the FDA’s blessing. This is as speedier review times requires manufacturers to be more flexible and work more closely with the FDA.

Camber’s Ostaficiuk emphasized that his company always has worked to streamline its processes to shorten approval time — thus minimizing time to market. Camber’s work with parent company Hetero Drugs and associate companies has resulted in an extensive pipeline of products and a unified approach to regulatory oversight.

“Our corporate strategy is to continue to have Camber, Ascent Pharmaceuticals and the Hetero Labs teams work closely with the FDA to submit and provide as much information as quickly as possible via electronic submissions to secure as many approvals as we can in 2019 and beyond,” Ostaficiuk said.

When it comes to seeking approval for biosimilars — lower cost, highly similar versions of protein-based biologic drugs — they need to provide more clinical data than is required in order to gain FDA approval.

Dr. Reddy’s Rao said biosimilars require the development of characterization data from a physical and chemical standpoint.

“The product needs to really mimic the brand,” he said, adding that the difficulty for companies is in creating a physically and chemically similar product — and proving it.

“With generics, a bioequivalent study is needed that is much simpler compared to a clinical study for biosimilars,” Rao said, highlighting the need for a qualified development team. “That’s where the cost is from an investment perspective.”

Looking Forward Cautiously
Though many manufacturers are optimistic that 2019 will be another record-b

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