Despite challenges, generics companies predict a rosy future
In 2021, patients in the United States received 6.4 billion prescriptions, 91% of which were generic and biosimilar medicines. The use of these lower-cost medications saved $373 billion for patients, consumers, employers and taxpayers, per the Association for Accessible Medicines’ September 2022 U.S. Generic & Biosimilar Medicines Savings Report.
But make no mistake—providing these cost saving drugs is a daunting task amid a head spinning landscape that is characterized by deflation, intense competition, escalating costs and product shortages.
Yet generics firms are unstoppable in the face of these challenges, as evidenced by their Herculean efforts to innovate, develop and launch new products, and ensure a supply of critical products.
This month, Drug Store News asked several generic drug company executives to discuss their latest innovations and to weigh in on the future of the industry. Their answers shine a light on the optimism in the industry.
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Drug Store News: Describe the innovations, or new products that your company has recently introduced.
Amneal
Andy Boyer, executive vice president, chief commercial officer of generics: In generics, we expect 20 to 30 new product launches each year. In the first four months of 2023, we’ve launched 10 new generics, and we are on track to deliver over 30 new products this year. Overall, we have 99 ANDA’s pending with the FDA with 63% representing non-oral solid products. This includes 32 injectables, 10 ophthalmics, 10 topicals, 6 oral liquids and 4 inhalation products. Behind that, we have 81 pipeline products with 89% representing non-oral solid products in complex categories.
In generic injectables, specifically, we see our cadence of innovation continuing as we remain on track to file 10 to 15 more ANDA’s in 2023, including many complex injectables. We look to file our first 505(b)(2) ready-to-use bags this year as well.
In inhalation, we recently completed clinical trials for generic ProAir and look to submit our ANDA shortly. In addition, we shared last quarter our new partnership to in-license the Soft Mist technology platform for the development of Respimat inhalation programs. We are pleased with the progress of our MDI programs, and expect to submit additional ANDAs in the coming years.
We are very excited about our ANDA for Naloxone nasal spray, our generic version of Narcan, which is currently under priority review with the FDA. We believe this product, which is now over-the-counter, will improve access to a critical, life-saving opioid overdose treatment for millions of people across America.
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Ascend Laboratories
John Dillaway, executive vice president: Ascend is always looking for ways to differentiate itself in the marketplace. While Ascend continues to have a robust pipeline and anticipates launching 12 to 15 new molecules annually, more often than not these new releases are met with significant competition.
One way Ascend is creating extra value with its customers is with the launch of its educational platform Ascend Academy. Through Ascend Academy, Ascend has identified a number of important and timely topics, such as intellectual property, impurities, KSM’s and several others that hold both interest and importance in today’s market. Ascend then identifies an expert on the subject matter who puts together a specific agenda that is then presented to specific customers. These presentations are best done in a classroom type setting where Ascend personnel go straight to the customer’s location and meet with any number of customer employees who believe they can benefit from the presentation.
If travel or space is a concern, the Academy can also present virtually. So far, Ascend has put on many of these presentations, mostly in person at customers’ locations and the content and delivery have been widely cheered.
Aurobindo
Paul McMahon, president, oral solids division, APUSA: Aurobindo Pharma USA is continuously striving to achieve product differentiation, specifically through formulation development and novel delivery methods of complex products. A recent product we are excited to announce, for which we received FDA approval, is diclofenac sodium topical solution, 2%. This is Aurobindo’s first product launch in the United States that is a topical product with a pump. Additionally, it is the first ANDA approval developed by our team in the AuroLife Unit, which is from our 40,000-sq.-ft. facility in North Carolina. In our North Carolina facility, meter dose inhalers, dry powder inhalers and transdermal patches are being developed by the specialty research and development lab site, which houses over 50 scientists, including highly experienced pressurized metered-dose inhalers, aerosols and transdermal R&D teams.
Diclofenac sodium topical solution is indicated for the treatment of the pain of osteoarthritis of the knee(s). It is the generic of Horizon Therapeutics’ Pennsaid. Diclofenac Sodium Topical Solution, 2% has a market value of roughly $334 million for the 12 months ending March 2023, per IQVIA.
Dr. Reddy’s Laboratories
Milan Kalawadia, senior vice president, chief commercial officer: Dr. Reddy's Laboratories announced the launch, in the U.S. market, of lenalidomide capsules, a generic of Revlimid. With this volume-limited launch, Dr. Reddy’s is eligible for first-to-market, 180 days of generic drug exclusivity for lenalidomide capsules in 2.5 mg and 20 mg strengths.
Marc Kikuchi, CEO, North America generics: "We are pleased with the first-to-market launch of two of our six strengths of lenalidomide capsules with 180-day market exclusivity. Bringing a more affordable generic version to market creates greater patient access for this important drug."
Hikma
Christopher Bonny, vice president of marketing and brand Rx operations: Hikma is a top 10 supplier of generic medicines in the United States and an important contributor to the U.S. healthcare system, expanding access to a broad range of injectable, oral, nasal and inhalable generic and branded pharmaceutical products for customers, healthcare providers and patients.
Our impact has been underscored by our continuing introductions of generic versions of important medicines, including Advair Diskus (fluticasone propionate and salmeterol inhalation powder). Within our specialty branded business, we also have delivered key innovations that are having a meaningful impact on the lives of U.S. patients.
We introduced Kloxxado (naloxone HCl) nasal spray 8 mg in the United States in 2021, for the emergency treatment of known or suspected opioid overdose. Kloxxado contains twice as much naloxone per spray as Narcan Nasal Spray 4 mg in a ready-to-use nasal spray to reverse the effects of opioid overdose, providing an important treatment option in addressing the worsening opioid epidemic.
And, last year we launched Ryaltris (olopatadine hydrochloride and mometasone furoate nasal spray) in the United States for the treatment of symptoms of seasonal allergic rhinitis (SAR). Ryaltris is the only fixed-dose combination therapy that provides relief for the symptoms of SAR, both nasal and ocular in one easy-to-use nasal spray.
Taro Pharmaceuticals
Anthony Dolan, executive vice president of generics (U.S. market): At Taro Pharmaceuticals, our vision is defined by reaching people and touching lives globally as a leading provider of valued medicines. Our mission is to meet the needs of our customers through innovation, development, manufacturing and marketing of the highest quality healthcare products.
Today, Taro has a generic portfolio with over 300 FDA approvals, including topical, oral and other dosage forms. More recently, Taro has introduced several notable products, such as a generic exclusive Naftifine HCl 2% Gel, Tretinoin Cream 0.025%, Alcohol Free Ibuprofen Oral Suspensions and Diclofenac Topical Solution 2%.
Taro continually invests in R&D, exploring new formulations, dosage forms and therapeutic areas. This proactive approach allows Taro to expand its product offerings, catering to emerging healthcare needs and filling gaps in the market.
DSN: What does the future of the generics industry look like?
Dolan: Taro has a strong focus on specialized therapeutic areas, such as dermatology, as a strategic advantage. Taro's expertise in niche segments provides us with a competitive edge, allowing us to address specific patient needs effectively. This targeted approach not only fosters patient trust but also offers long-term growth potential.
In addition to Taro's commitment to maintaining high-quality standards, the company is dedicated to producing first-to-file generic products.
Through these efforts, the company plays a role in enhancing access to affordable medications and benefiting patients worldwide.
Over the past 70+ years, Taro’s commitment has remained the same: Growth through R&D in a wide range of therapeutic forms; high-quality generic portfolio across international markets and becoming the leading manufacturer/supplier in dermatological.
Bonny: More broadly, the industry continues to work on providing a strong, affordable and high-quality supply of generic medicines, and on addressing ongoing shortages of essential medicines. Our high-volume and state-of-the-art U.S. manufacturing facilities have an excellent record of FDA quality inspections. As Congress, the FDA and others look at ways to improve the availability of high-quality generics manufactured in the United States, we are well-positioned to meet this need.
Boyer: In generics, from a manufacturer’s perspective, the size and diversity of a company’s product portfolio matters tremendously. For Amneal, our diverse portfolio of approximately 230 retail generic products is continually expanding, moving up the value chain of complexity and it has continuously grown over the years.
Another key concern is access to medicines and supply chain resiliency. Supply shortages have increased in the market for a variety of reasons, including increased demand for certain products, manufacturer shortages due to discontinuations, among a number of other issues. Overall, there is a need to secure America’s pharmaceutical supply chain by ensuring that essential medicines are manufactured in the United States. This was a clear lesson from the pandemic. From raw materials to finished products, domestic manufacturing is critical for the security and viability of our U.S. supply chain long-term.
Dillaway: It has been a difficult few years for generic manufacturers given historic deflation, unrivaled competition and now facing additional new expenses from serialization, opioid and DEA fees and state stewardship (drug takeback) programs. Cumulatively these factors are starting to cause casualties among manufacturers with several going out of business, several others in Chapter 11 and many others on a pathway there. This direction will continue over the next several years transforming the manufacturing landscape. In order to prevent this, behavior from both buyers and sellers must change. Each must recognize the value in the other and look to replace what has become a transactional relationship with a more partnership relationship. Can this happen? It will be a challenge given the precedent of behavior to date, but with survival at stake let’s have an optimistic view.
McMahon: In fiscal year 2023, Aurobindo led the market in ANDA approvals and filed 49 ANDAs and received final approval for 59 ANDAs. In addition, the company successfully launched and relaunched 24 products. Aurobindo Pharma looks forward to launching many more products in the coming months, as the company continues to expand its portfolio with nearly 200 pending approval. This brings us to over 700 FDA approved ANDAs to date.
Aurobindo continues to invest in infrastructure in terms of plant and capacity expansions and building new facilities, all of which will fuel our growth. We are pleased to announce our new Luoxin facility, located in China, where we’ll be producing the blow-fill-seal inhalation products, the first of which will be levalbuterol, followed by albuterol, ipratropium and others, beginning early next year, if all goes to plan. Aurobindo remains focused on strengthening our existing businesses and developing a differentiated and specialty-driven product portfolio.
Kalawadia: It’s a very competitive marketplace. While we may feel that we’re doing something unique from a product selection standpoint, or that we have a unique capability, the reality is that if you look across the competitors out there, somebody is doing what we’re doing. One of the big challenges is, you need to continue to be quick to market with products. You’ve got to continue to innovate, select the right products to develop and quickly come up with strategies where you can try and differentiate your products.
You also need to make sure that you are as cost-competitive as possible, because the market dynamics are quite competitive and change rapidly. If you are late to market, you’re going to struggle to get market share. And, if you’re not cost-competitive, you will not succeed in a particular product and hence the long-term viability of an asset may or may not exist. On top of that, we are going to continue to grow and build our portfolio to have a very robust offering to compete with the key players in the market. The top competitors will continue to have large portfolio offerings and will need to continue to ensure that we have that value-added offering.
That’s the norm now. Best pricing, lowest pricing is a key and it’s going to have an impact on margin profiles, but at the same time it’s a generic industry. So, the key to success is increasing the number of new products we launch every year and to be first to market. That’s going to be a critical aspect and I’m sure all generic players are focused on improving their portfolio offerings year on year.